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2009: The Year Implant Direct Transformed the Implant Industry with True Innovation and Value |
In 2009, Implant Direct completed its third year of sales operations (after 3 years of product development) with a 60% sales increase over 2008 on a global basis. Implant Direct Int'l now has more than 250 employees with offices in California, Nevada, Vancouver, Zurich and Tel Aviv, as well as distributors in over 30 countries. Our manufacturing facility added 6 new CNC machines to keep up with our expanding sales, taking the total to 33, and we went to 24/7 production taking advantage of our unique ability to run lights-out. Implant Direct is proud to have accomplished this explosive growth during a period of global recession with the major implant companies experiencing sales losses of 10-20%. We did this while maintaining, and in several instances, lowering our list prices on existing products. Implant Direct was also able to launch several new and innovative implant systems (SwissPlant, GoDirect, Legacy3). We anticipate continued growth in 2010 with the software and hardware in place to produce CAD milled bars, image guided surgical templates and zirconium abutments. Implant Direct has on order 4 more CNC Screw Machines for April delivery and we will be operating out of our new 8,000 sq. ft. shipping offices in Las Vegas by January 1, 2010, freeing up space in our Calabasas manufacturing facility to expand our clean room packaging operations. With an average of 15-20 new customers a day in North America alone, Implant Direct's business model of focusing on value, innovations and customer service is proving that our logo "Simply Smarter" applies to our way of doing business and to our customers as well.
President, Implant Direct LLC
GNiznick@ImplantDirect.com
www.implantdirect.com
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Year In Review
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July 2009
"Implant Direct Launches Three New Implant Systems"
In this issue...
- Legacy3 - The Next Generation of the Legacy Line of Implants
- SwissPlant - The Next Generation Straumann Compatible Implant
- GoDirect - The Locator™ Attachment Compatible Implant
- New Online Shopping Cart
- Shop Floor Efficiency and Technology
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September 2009
"Nobel Biocare's 'Sterile' Packaging"
In this issue...
- Medwatch Report Filed On Nobel Biocare's Sterile Packaging
- Implant System Overview Available
- Transforming The Implant Industry - New Online Video
- Legacy3 - ReActive - SwissPlant Implant Line Additions
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December 2009
"The
Year In Review"
In this issue...
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Go-Direct 1-Piece Implant (3.0mm, 3.7mm & 4.7mm) with Locator™ Compatible Platform |
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In 1982, Dr. Gerald Niznick, a member of the AAID since 1971 and recipient of the Gershkoff Award, published a 40 page article on the Core-Vent System, documenting the first use of osseointegrated implants functioning free-standing to retain a lower overdenture. The article also broke new ground documenting numerous cases of immediate placement of implants in extraction sockets with abutments added for bar overdenture restorations.
In 2009, Dr. Niznick's Implant Direct Company will launch the GoDirect 1-piece implant with a Locator™ compatible platform adding to his Spectra-System line that already includes the
1-Piece ScrewIndirect implant designed for screw-retained bar overdentures and fixed-detachable restorations.
Every dentist placing implants will want to add these cost effective, time-saving implant options to his or her practice.
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ScrewIndirect 1-Piece Implant (3.0mm, 3.7mm & 4.7mm) with Screw-Receiving Platform |
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Legacy 1-2-3 Implant System |
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Twenty-Three years after Dr. Gerald Niznick introduced the first conical connection with an internal hex, Implant Direct Int'l launched the Legacy1, 2 and 3 Systems, expanding the surgical and prosthetic options with the most copied platform in the implant industry (Niznick US. Pat. #4,960,381 expired October 2007). All three systems share the same surgical protocol, color coded prosthetic platform and surface options of SBM or HA ($25 extra). Dentists make their selection based on cost, which varies based on a choice of fixture-mounts. All three implants provide double-lead body threads for faster insertion and quadruple lead mini-threads near the top for increased stability and reduced stress concentration in the critical crestal area. All the Legacy Implants are packaged with a surgical cover screw and an extender for use as a 2mm healing collar.
"It's as Simple as 1, 2 and 3"
Legacy1 - $125 — 3 Diameters: Designed with an evenly tapered body, "V" thread and
two self-tapping grooves over the lower half. The implant is delivered on a color-coded, plastic carrier for ease of insertion and economy.
Legacy2 - $150 — 4 Diameters: Designed with the coronal 1/3 straight and the apical 2/3rds
tapered for maximum bone expansion. Aggressive self-tapping and bone expansion is accomplished with the combination of flat-based, spiral threads and three deep
self-tapping grooves that extend from the start of the taper, converging at the apex. The implant is delivered on a color-coded, titanium alloy carrier which can be used
during the restorative phase as a transfer and a temporary abutment.
Legacy3 - $175 — 6 Diameters: Designed with evenly tapered body with progressively deeper,
flat-based "buttress" threads for increased surface area and two self-tapping grooves extending half way up the implant. The Legacy3 includes 3.2mmD, 4.2mmD and 5.2mmD
implants with a platform shifting interface. The implant is delivered on a color coded, titanium alloy carrier that can be used as a closed-tray transfer and a
full-contour, preparable abutment.
The Legacy System offers the industry's broadest selection of abutment options that can be used with the Zimmer Dental, BioHorizons and MIS implants
having the same lead-in bevel, internal hex platform.
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Patent Approved for Micro-thread design |
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Reasons for Allowance of Claims:
"In regard to the prior art rejection based on Hansson ‘564, the examiner finds applicant's remarks persuasive and adopts them as his own. Moreover, while mindful of the guidance given in KSR International Co. v. Teleflex Inc. 550 US 398 (2007), the Examiner notes that the present claims require more the selection of a particular ratio of threading between proximal and distal regions, but also require that the pitch and alignment of the threads between the two portions are such that the threads of the proximal region fit into the jawbone threads formed by the distal region or cut into bone between the jawbone threads without cutting across the jawbone threads. The examiner finds the claimed particular ratios in combination with the required formation of the pitch and alignment between the two portions to be nonobvious."
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Implant Direct Mini-thread Design: Double-lead threads on body for faster insertion with Quadruple-lead threads starting 1mm below the crest of the bone, creating mini-threads that are 1/2 the depth of the body threads. 2 of the 4 mini-threads align with the threads pre-tapped in the bone by the double-lead body threads with the other two self-tap new threads in the peaks of the bone threads for increased stability |
Astra Mini-thread Design, going from Single-lead threads on the body with Triple-lead threads starting at the crest of the bone, creating mini-threads that are 1/4 the depth of the body threads. Only 1 of the 3 mini-threads aligns with the threads pre-tapped in the bone by the body threads with the other two threads crushing the peak of the bone threads. |
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RePlant™, RePlus™ and ReActive™ Tri-lobe Implants |
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History of the Tri-lobe Connection:
During the 1980's and 1990's, Nobel Biocare ("Nobel"), through its paid opinion leaders, proclaimed the Branemark External Hex connection as the "gold standard" in spite of a well documented history of screw-loosening and the necessity to take X-rays to confirm full seating. Dr. Gerald Niznick developed the first internal connection in 1986 (patent # 4,960,381 issued in October 1990 and expired 2007) for Core-Vent Corporation’s Screw-Vent™ Implant. Today, almost 24 years later, the Screw-Vent implant with its lead-in bevel and internal hex, is the mainstay of the Zimmer Dental product line. Some major companies, such as Friadent, 3i, BioHorizons, Steri-Oss and Straumann took licenses on this patent while other U.S. companies were prevented from infringing by enforcement of the patent prior to its expiration in October 2007. There are many other companies in Israel, Europe and South America where the Niznick patent was never filed, who also duplicated the original internal connection.
In 1998, Steri-Oss introduced the Replace™ Implant with a tri-lobe, butt-joint connection. Nobel acquired Steri-Oss in 1999 and promoted this internal connection as: "What every dentist wants…an internal connection," acknowledging that its Branemark external hex implant was not what its customers wanted. Nobel received a patent for the Tri-lobe connection in 2004 preventing competitors from making compatible implants until Implant Direct launched the RePlant™ System in 2006. Implant Direct’s tri-lobe connection is
similar to and compatible with Nobel’s, including the color coding, but varies by creating a second set of internal tri-lobes that provide double the length of engagement for the Implant Direct’s multi-functional, titanium fixture-mounts. This improved double tri-lobe design earned Dr. Niznick his 34th patent, avoided infringement and accepted Nobel’s tri-lobe abutments with as good or better precision fit.
In 2008, Nobel acquired Alpha Bio Tech, an Israeli implant company that built its business by copying the Screw-Vent Implant system. Today Alpha Bio still sells implants with the Niznick/Screw-Vent internal 44 degree bevel above a hex. Its catalog refers to this design as “the Perfect Implant-Abutment Connection.” After Nobel acquired Alpha Bio, it introduced the NobelActive™ Implant, similar to Alpha Bio’s SPI spiral thread implant, but with a 78 degree lead-in bevel above the internal hex. A comparison of the Legacy3 and NobelActive implant demonstrates why the NobelActive connection creates difficulty in determining by tactile sense alone, if abutments and transfers are fully seated. |
In 2007-2008, Implant Direct expanded the RePlant system to include the RePlus™ Implant and ReActive™ Implant, both with the RePlant double tri-lobe connection. The ReActive and NobelActive Implants provide progressively deeper threads for increased surface area. Unlike the NobelActive, all Implant Direct Implants have micro-threads to reduce bone loss and a round apex to avoid deviating from the established bone socket during insertion or tearing the sinus membrane. The ReActive implant was developed to provide Nobel customers with an aggressive thread option without abandoning the tri-lobe color-coded platform they had become familiar with. Implant Direct’s Legacy™ System provides the original Niznick lead-in bevel, internal hex connection that provided the tactile sense to eliminate the need to take X-rays to verify full seating. In 2009, it was expanded to include the Legacy3 with the same body and threads of the ReActive implant.
In 2009, Implant Direct improved the packaging on the RePlant Implant with a two-piece titanium fixture-mount that can be used as a transfer. The fixture-mount can be shortened for used as a temporary abutment, or for converting a patient's denture in a Teeth-in-1Day™ procedure. Implant Direct added a Dual Grip configuration to the screws and healing collars of its tri-lobe implants, allowing use of a standard 1.25mm (0.05”) hex tool or Nobel's "Unigrip" tool. These improvements were made without any increase from the $150 launch price of the RePlant Implant. Implant Direct’s tri-lobe implant system offers Nobel customers significant cost savings, the convenience of all-in-one packaging and design improvements that have been shown to increase clinical success.
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Update On Nobel Packaging |
Response to Nobel's Misleading Marketing in Canada |
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Nobel Biocare's NobelActive implants failed standard dye leak tests required to confirm seal integrity of products labeled as sterile. Implant Direct's investigation of Nobel Biocare's packaging was triggered by Nobel's decision to misrepresent Implant Direct's Canadian voluntary recall of a small quantity of implant vials sold during a 14 week period in 2007. The recall resulted in the exchange of only 7 implant vials and related to cosmetic micro-cracks in the caps. Health Canada Website confirms that "Testing indicates the integrity of the packaging was maintained". Nobel's involvement in instigating the recall itself is in question because the packaging issue was brought to the attention of Health Canada by a disgruntled Implant Direct employee who went to work for Nobel in July 2009 for the expressed purpose of using a recall to discredit Implant Direct. That employee was hired in July 2009 and let go by the end of November 2009 after Health Canada advised Nobel that using recall information for marketing was against their regulations. Nobel's involvement in this sordid affair triggered a chain of events that has resulted in a Medwatch report being filed with the FDA after Nobel's packaging failed standard dye leak tests used to validate seal integrity. The fact that Nobel Biocare circulated false and misleading information about the significance of Implant Direct's voluntary recall while not addressing its own packaging issue exposes the depths to which Nobel was prepared to go to combat the migration of its customers to Implant Direct's products. |
Health Canada and the FDA have investigations ongoing on Nobel's packaging and labeling issues. Nobel claims that it validates its sterility and/or seal integrity using a different test than the standard dye leak test but has refused to provide the name of the test or the results to any of the stock analysts who have requested this information.
According to a Chief Science Officer at an FDA certified testing laboratory:
"If a manufacturer sent us packaging samples from a validation (not R&D) for dye immersion, or for that matter any ISO11607 recommended packaging test, and we saw failures, our approach would be to investigate why the samples were failing, then notify the customer of the nature and location of the failure. We would decline to test packaging from the same unmodified process for a different method in an attempt to obtain passing packaging results. That would be selecting data and is unacceptable."
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SwissPlant Dental Implant
System |
The SwissPlant System represents the
first line of implants designed for insertion at
tissue-level, bone-level or anywhere in between.
This is demonstrated in our surgical video. The 4.1mmD and 4.8mmD SwissPlant
implants offer surgical compatibility with
Straumann's drills in soft bone with an additional
drill required for dense bone. The 4.8mmD and 6.5mmD
platforms are prosthetically compatible with
Straumann's abutments, having the same internal
octagon licensed to Straumann by Dr. Niznick (U.S. Patent # 4,960,381) and an 8
degree lead-in bevel. In addition, they have an
internal square for engagement via the color coded
fixture-mount for insertion. The fixture-mount also
serves as a transfer and can be shortened for use as
the final 5.5mm high straight abutment. Each implant
is packaged with a snap-on comfort cap and 2mm
healing collar for added value. Adding to the
versatility of the SwissPlant System is a 3.3mmD
implant with a 3.7mmD platform and a 5.7mmD implant
with a 6.5mmD platform, all available in 5 lengths
including, a 6 mm long implant. The SwissPlant
implants include micro-threads and progressively
deeper flat-based (Straumann) threads, first
developed for the ReActive implant, providing
increased surface area for increased stability in
soft bone.
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SwishPlant™, SwishPlus™ and SwishActive™ Implants |
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Definition: adjective - elegant, smart, perfect |
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Implant Direct Broadens its product offering for
Straumann Customers |
Straumann, the Swiss Implant Company that pioneered the one-stage (tissue-level) implant finally realized that a two-stage (bone-level) implant was also needed for the esthetic zone. Pushing the smooth neck sub-crestal to lower the margin increased the probability of bone loss. Apparently they also realized the difficulty in selling high priced implants in these troubled economic times. An article in a Swiss business magazine in May 2009 and a more recent article in a Zurich newspaper made it very clear to Straumann that Implant Direct represents a price-point shift in the implant industry that could no longer be ignored. Instead of responding with better products at better prices, Straumann took issue with the name of Implant Direct's SwissPlant implant system, demanding that it be changed because SwissPlant implants are not made in Switzerland. Implant Direct had named it's product SwissPlant because of the surgical and prosthetic compatibility with Straumann's tissue-level implant, which has an internal connection licensed to Straumann in 2000 under the Niznick Patent #4,960,381. Implant Direct is proud of the fact that it makes all of its products in United States and responded to Straumann's challenge by changing the product name to SwishPlant. The definition of the adjective "swish" is "smart, elegant or perfect." Having been prompted to change the name by Straumann, Implant Direct decided to broaden the Swish™ line to bring even greater surgical versatility and cost savings to Straumann's customers as shown below in the new Swish-System of products.
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Bone-level Implant - $150 – 3 Diameters:
- Available in 3.3mmD, 4.1mmD and 4.8mm Diameters
- Conical connection matching the Legacy internal hex platform
- Surgically compatible with Straumann's Tissue-level implants
- Self-tapping with Micro-threads
- Fixture-mount is a transfer and temporary abutment
- Cover-screw and 2mm Healing Collar included
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Tissue-level Implant - $175 – 3 Diameters:
- Available in 4.1mmD and 4.8mmD with Straumann compatible Platforms and 3.3mmD with the Legacy internal hex platform
- Surgically compatible with Straumann's Tissue-level implants
- Self-tapping with Micro-threads
- Fixture-mount is transfer and straight abutment, with snap-on comfort cap included
- Cover-screw and 2mm Healing Collar included
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Bone- and Tissue- level Implant - $200 – 5 Diameters:
- Available in 4.1mmD and 4.8mmD with Straumann compatible Platforms and 3.3mmD with the Legacy internal hex platform
- Surgically compatible with Straumann's Tissue-level implants in soft bone with an additional drill required for dense bone
- Self-tapping with double-lead body threads and micro-threads
- Fixture-mount is a transfer and a straight, preparable abutment with a pre-machined margin
- Cover-screw and 2mm Healing Collar included
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The SwishPlant™ bone-level and SwishPlus™ tissue-level implants are surgically compatible with Straumann's
Tissue-level Implants. The SwishActive™ is the same body as the current SwissPlant with a different fixture-mount. |
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Implant Direct Initiates Direct Marketing Strategy For Its Customers Using RealChoice Trademark And Web Site
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In these uncertain economic times, dentists need to be proactive in their efforts to expand or even maintain their dental practices. Implant Direct gives you the hardware to offer cost-effective implant treatment and now has developed the marketing strategy available at no cost to our customers. Our RealChoice™ implant center program provides you with a free, customized website and ad copy to market your practice under the umbrella of a third party endorsement. Increase your practice revenue through direct to consumer marketing of implant procedures including Teeth-in-1Day™ for the edentulous upper and lower jaws. With our GoDirect™ one-piece implants with a Locator™ compatible platform, you will be able to place 2 implants in the lower jaw to stabilize a denture for only $400 in hardware costs. With our ScrewIndirect™ one-piece implants with a screw-receiving platform, you will be able to convert a denture into a fixed-detachable restoration supported by 5 implants for under $1,000 in hardware costs. Visit our website and register for additional information on how to become a RealChoice Dental Implant Center.
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3 FREE IMPLANTS AND PROSTHETICS
Proof of purchase of implants from an Implant Company listed below is required!
Disclaimer: The logos below are the registered trademarks of their respective companies. Implant Direct does not sell products manufactured by any of these companies.
Click on a Company Logo* For Comparative Information And Suggested Free Implant Offers
These introductory offers are for first time purchasers of implants from Implant Direct.
Dentists who did not take advantage of any introductory offers
on their first purchase may do so within 90 days of their first
purchase. One Introductory Offer is provided per dentist, dental office, group practice or partnership regardless of whether the dentist(s) practice in multiple locations. |
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Call 1-888-649-6425 to speak with a Technical Sales representative.
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Implant Direct LLC Customer Service Center., 26330 Diamond Place #100 Santa Clarita, CA, 91350 U.S.A.
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Locator is a registered trademark of Zest Anchors Inc. - Teeth-In-1Day is a registered trademark of Implant Direct LLC - Screw-Vent is a registered trademark of Zimmer Dental Inc.
NobelActive is a registered trademark of Nobel Biocare. Straumann is an international trademark by Institut Straumann AG.
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