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SPECIAL INDUSTRY REPORT ON COMPARATIVE CLINICAL SUCCESS
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Nobel
falsely claimed Implant Direct's RePlant™ could not be
inserted using NobelReplace™ Drills |
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In Implant Direct's August 2007 newsletter, Dr. Gerald Niznick published a 12 page technical report refuting Nobel's disinformation regarding the compatibility between Implant Direct RePlant™ Implants and the Nobel Replace™ line of surgical drills. Entitled, "The Inside Story On Nobel Biocare's Marketing Strategy In North America" the report detailed Nobel's attempts to derail the growing number of converts to RePlant™ through a campaign designed to raise doubts about the legitimacy and legality of Implant Direct's claims of compatibility. As illustrated in the report, Implant Direct obtained US-FDA 510k marketing clearance to claim compatibility: "The seventh implant of the Spectra-System, the RePlant™ matches the tapered body dimensions and tri-lobe platform of the Nobel Biocare Replace™ Tapered implants and therefore can be inserted using Nobel Biocare drills." The two implants have matching dimensions but RePlant alone offers micro-threads and self-tapping vertical cutting grooves. Implant Direct eventually received a patent on its double tri-lobe platform that accepts Nobel abutments. Implant Direct eventually introduced its own set of surgical instruments at substantially less cost that can be used for both companies' products. Two clinical reports showing a significantly higher success rate with RePlant™ implants than Nobel Replace™ implants using Nobel Replace™ drills, puts to rest once and for all the question of surgical compatibility raised by Nobel's defensive marketing strategy. |
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Published Online August 2007
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Multi-Center Controlled Study Reports 13% Failure With Nobel
Replace™ And 1% With RePlant™ |
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2nd MedWatch Report Documents 38.6% Failure With Nobel Replace™
And 3.8% With RePlant™ |
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An experienced implant dentist
(Member of AAID and ICOI) filed a FDA MedWatch report
February 20, 2010 citing high failures with Nobel Replace™
Implants which he related to the company's questionable sterile packaging. From
August 2006 until January 2010 he documented the results of
88 consecutively placed implants, 34
required removal for a stunning rejection rate of 38.6%.
By contrast this same dentist placed
51 RePlant implants from Implant Direct with only 2
implants requiring removal for a success rate of 3.9%.
Both the RePlant™ and Replace™ Implants were
inserted using Nobel Replace™ surgical drills following an
identical surgical drilling protocol, as approved by both companies.
The dentist brought his concerns about high failures to the
attention of Nobel by completing
Nobel's exchange forms and then when the failures continued he requested that
Nobel take back his remaining inventory, in a letter to
Nobel's US Corporate Counsel. Nobel refused to take back his remaining inventory.
The dentist continued to use up his Nobel inventory but also started using Implant
Direct's RePlant™ implants in 2008. When failures continued to mount with
Nobel Replace implants, he stopped using them altogether and switched exclusively
to using RePlant™ implants.
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Study Results Show 88 Nobel Replace™ Implants Placed With 34 Failures - 38.6%
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Study Results Show 51 RePlant™ Implants Placed With 2 Failures - 3.8%
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Failed Dye Immersion Test - ISTA Certified Laboratory
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Click Image To View Abstract
Click Here To View/Download Complete MedWatch Report
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He learned of Implant Direct's
MedWatch report in regards to Nobel's packaging and the
potential lack of seal integrity that could result in a loss of sterility.
He contacted Implant Direct for assistance
on testing a portion of his remaining Nobel Implants.
The dentist sent two groups of
his remaining implants for dye penetration leakage testing to two FDA
certified laboratories. The first
batch of seven implants was sent to Nelson Labs, a USFDA
certified laboratory headquartered in Salt Lake City, Utah.
A second batch was sent to WuXi AppTec of Marietta Georgia.
itself an
ISTA Certified Laboratory.
The results of these tests were:
The dentist then did a retrospective case
series study of his patient records showing 10x greater
failure rates with Nobel Replace™ in stark contrast with his
success using RePlant implants.
As Implant Direct reported previously, the fact that Nobel's packaging
fails predictably (100% of all tested samples to date)
indicates potential lack of a sterile barrier which could
contribute to real or potential patient harm. If other
dentists have had similar negative experiences, they should
report them to the FDA, which has an investigation currently
underway.
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National Discount Registry - The 'Real Deal' That Premium Implant Companies Offer
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Implant Direct has
created a "price point shift" in the implant industry by
offering a broad product line of high quality implants with
All-in-1 packaging and 1980's prices. In a January 2010
Implant Industry Report by Berenberg Bank, it was noted that
Implant Direct is, "more than a so-called internet
discounter and is moving towards the pack of value/premium
players albeit at a significantly lower price point."
Implant Direct believes closing the gap between
the list prices of its implants, starting at
$125 and those of Nobel Biocare, Straumann, 3i,
Zimmer Dental, Astra and BioHorizons, starting
at over $300 will help our business because the
70% price difference acts as a barrier to some
dentists who mistakenly believe that higher
prices somehow assures higher quality or greater
success. We prefer to reduce this gap by forcing
the prices of our competitors down, rather than
raising our prices. Nobel Biocare and Zimmer
Dental, in particular, have aggressively
discounted their prices to try to retain
customers from switching to Implant Direct. We
suspect that Straumann will do the same when
Implant Direct
launches its new SwishPlant, SwishPlus and
SwishActive implants later this year,
expanding compatibility and lowering prices. GPs buying just the
prosthetic components have very little, if any,
negotiating leverage.
Implant Direct has created an on-line Discount
Registry to create transparency to the selective
discounting practices of many premium priced
companies. For those dentists who choose to
continue buying implants from our competitors,
this will provide the information needed to
negotiate lower prices. |
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Read the 2008 Blog on Cafepharma that
started the concept of this
National Discount Registry |
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All submissions, whether by salespeople or
dentists, will be posted anonymously but
verification records will be kept on file by
Implant Direct. It is unlikely that Nobel
Biocare or ClearChoice will reveal the discount
deal they have negotiated which indirectly funds
the huge advertising budget of ClearChoice, in
competition with dentists in the areas of their
21 offices. Military personnel may have the
authority to explore this issue because US
government contracts mandate that the military
should receive the company's lowest discount.
Implant Direct is aware of dentists that
effectively negotiated 40% - 60% volume
discounts from Nobel Biocare and Zimmer Dental,
inclusive of price reductions, product exchanges
and free ancillary products, in order to switch
customers back from Implant Direct. Implant
Direct does not discount from its everyday low
prices, regardless of volume purchases and has
lowered the price of several of its implants
over the last three years. We do provide
one-time introductory offers of either 3 free
implants, 5 free implants with the purchase of
20 implants or a surgical instrument kit with an
initial purchase of 50 (basic kit) or 100
implants (complete kit).
Negotiating Strategy: To increase your
negotiating leverage, simply order Implant
Direct's 3 Free Introductory Implant Offer,
place the implants and then show your rep an
X-ray pointing out the features you like with
this system such as its All-In-1 packaging,
micro-threads, self-tapping grooves, diameter
and platform options, etc. When they do offer
you an additional 10% discount, refer them to
Implant Direct's Discount Registry and tell them
that they have been overcharging you for years
and you expect an additional 20% discount
(assuming you are not getting more than 25%
discount already). You will be surprised how far
they are authorized to go and what additional
free products (healing collar, drills,
abutments) they are prepared to throw in if they
think it will help retain your business. If the
sales rep comes back with claims of superior
customer service to justify higher prices, point
out that Implant Direct has 60 customer support
staff in the US, a website with 3D graphic
educational videos on every procedure and the
industry's most intuitive on-line shopping cart.
After negotiating lower prices, Implant Direct
hopes you will then objectively evaluate how
much better Implant Direct's products are - at
any price. |
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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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Implant
Direct's Tri-Lobe Family Of Implants |
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Straumann Compatible Abutment Kit - Save over 50% vs. Straumann
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Click Image For Larger View
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Implant Direct has taken its
innovative All-in-1 packaging philosophy to a new level with
the introduction of the Straumann compatible SwissPlant Abutment
Kit.
The straight one-piece abutment does not engage the internal
octagon of the implant and has an internal feature which
allows for tightening with either a 1.25mmD Hex Tool or
the SCS driver tool from Straumann.
The abutment is designed to
interface with either the standard 4.8mmD internal octagon
platform from Implant Direct's SwissPlant product line or
the ITI Straumann 4.8mmD platform.
Each Abutment Kit contains:
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Abutment
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Abutment transfer
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Comfort Cap
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Abutment Analog
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Castable Coping
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1-Piece Solid Abutment |
2-Piece Abutment |
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Implant Direct is
offering the Solid Abutment Kit for $100 compared to
Straumann's at $238 and the 2-Piece Abutment Kit for
$110 compared to Straumann's unit price of $290.
Please review the video to explore the features and
versatility of the kit. |
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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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