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SPECIAL INDUSTRY REPORT ON COMPARATIVE CLINICAL SUCCESS

Nobel falsely claimed Implant Direct's RePlant™ could not be inserted using NobelReplace™ Drills

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.


Published Online August 2007

Multi-Center Controlled Study Reports 13% Failure With Nobel Replace™ And 1% With RePlant™


Multi-Center Study Results:
13% Failure Rate Using Nobel Replace™
Compared To 1% Using RePlant™

"All-on-Four" Case Study By Dr. Pedro Pena

Treatment Options For Restoring Edentulous Jaws

Compare Advantages
of RePlant™ To
Nobel's Replace Implant

Teeth-in-1Day Using
ScrewIndirect Implants

Teeth-in-1Day Using
RePlant Implants

2nd MedWatch Report Documents 38.6% Failure With Nobel Replace™ And 3.8% With RePlant™

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.


Study Results Show 88 Nobel Replace™ Implants Placed With 34 Failures - 38.6%

Study Results Show 51 RePlant™ Implants Placed With 2 Failures - 3.8%
After testing (control is 2nd from left)
Failed Dye Immersion Test - ISTA Certified Laboratory

Click Image To View Abstract
Click Here To View/Download Complete MedWatch Report


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.

February 2010 MedWatch Report Sections:
Medwatch Report:
Description of
Problem
Filed with FDA
Attachment #1:
88 Nobel RePlace
implants with
38.6% Failure
Attachment #2:
51 Implant Direct
RePlant™ implants
with 3.9% Failure
Attachment #3:
Letter to Nobel
Biocare's Attorney
regarding failures
Attachment #4:
Nobel Biocare
Implant Guarantee
Exchange Forms
Attachment #5:
Failed Dye Leak
Test from Nelson
Laboratories
Attachment #6:
Failed Dye Leak Test
from ISTA Certified
Laboratory
Dr. Niznick Answers A Question On The JIACD Blog:
Why Change From The Nobel Implant System?

Price: Save 70%
Strength: Titanium Alloy
Design: Self-Tapping and Micro-Threads
Surgical Compatibility With High Success Rate
Sterile Packaging Assured
All-In-1 Packaging
Platform Switching

National Discount Registry - The 'Real Deal' That Premium Implant Companies Offer


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.

 

 


Read the 2008 Blog on Cafepharma that started the concept of this
National Discount Registry

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.

RePlant™, RePlus™ and ReActive™ Tri-lobe Implants

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.

 Implant Direct's Tri-Lobe Family Of Implants

Tale Of Two Systems RePlant Surgical Tray New RePlant Packaging 30-60-90 Offset Abutments

Comparing Legacy3 To
Nobel Active

View Tray Contents

View PDF

View PDF View Video
RePlant Packaging RePlant Surgical
Hi Res Low Res Hi Res Low Res
RePlus Packaging RePlus Surgical
Hi Res Low Res Hi Res Low Res
ReActive Packaging ReActive Surgical
Hi Res Low Res Hi Res Low Res
RePlant Fixture-Mount
Restorative Procedures
RePlus Fixture-Mount
Restorative Procedures
Hi Res Low Res Hi Res Low Res
ReActive Fixture-Mount
Restorative Procedures
Teeth-In-1Day Procedures Using RePlant Implants
Hi Res Low Res Hi Res Low Res

Straumann Compatible Abutment Kit - Save over 50% vs. Straumann

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:

  • Abutment
     

  • Abutment transfer
     

  • Comfort Cap
     

  • Abutment Analog
     

  • Castable Coping

1-Piece Solid Abutment 2-Piece Abutment

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.

Introductory Offers

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

Straumann

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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Locator is a registered trademark of Zest Anchors Inc. - Teeth-In-1Day is a registered trademark of Implant Direct LLC.
Nobel Replace is a registered trademark of Nobel Biocare.