Nobel Biocare Letter

Letter to Mr. Kevin Mosher, VP and GM, Nobel Biocare North America Response to Nobel Biocare’s Misleading Marketing Attack on RePlant Compatibility Implant Direct Receives FDA Marketing Approval to Claim Surgical Compatibility Implant Direct’s 510(k) Approved Submission States: “The Spectra-System consists of seven implants with external thread configurations consisting of double lead threads over the body of the implant and 2mm-2.5mm of quadruple lead mini-threads near the coronal portion of the implant. … 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 utilizing Nobel Biocare drills.” Dear Mr. Mosher: I have requested that Nobel Biocare (“Nobel”) cease circulating a series of slides claiming that Implant Direct’s RePlantTM Implant is not surgically compatible with Nobel’s drills for its Tapered Groovy Replace Implant. As seen above, the FDA has approved this marketing claim based on submitted engineering drawings and test results. Furthermore, thousands of RePlant implants have been placed by Nobel’s former customers using Nobel’s drills without a single complaint to Implant Direct as to a lack of compatibility. Implant Direct does not claim that its RePlant implant is the same as Nobel’s Replace implant, only that it can be insertAlbrektsson, Branemark 1982 ed using NobelReplace drills because the diameters of the collar and threads of both implants are the same. Merriam-Webster Dictionary defines “compatible” as Clin. Applications in Biomaterials “Fibroblast Soft Tissue” “designed to work with another device or system without modification” in contrast to the word “same” that is defined as “corresponding so closely as to be indistinguishable”. Nobel, apparently unwilling or unable to compete with Implant Direct on product features and prices, has, at your direction, implemented a campaign of disinformation to impede your customers from making an informed judgement about whether they want to spend $452 for a Nobel Replace Implant, cover-screw and transfer or $150 for a RePlant Implant, cover screw and transfer. Since you have only been with Nobel for three years, you may not be familiar with Nobel’s history of using questionable marketing claims. The pictures on the right show deception on a very basic level, by representing that a colorized SEM of a Branemark et.al: JPD 1983 Fibroblast from soft tissue around an ear implant was an Osteoblast from an “Osteoblast Upper Jaw Fixture” upper jaw Branemark osseointegrated implant. In the early 1990’s, Nobel was found liable for Anti-trust violations http://www.implantdirect.com/Pdf/USCourtofAppealsfortheFederalCircuit.pdf enforcing a patent gained by fraud. The Swedish Medical Products Agency has imposed restrictions on Nobel’s marketing claims and investigated reports of excessive bone loss around Nobel’s Implants http://www.implantdirect.com/speaksout3.htm AFX News Limited: Nobel Biocare CEO under pressure over dispute with Swedish authorities - report 07.29.07, 11:30 AM ET ZURICH (Thomson Financial) - Nobel Biocare AB chief executive Heliane Canepa has come under fire over allegations that the Swedish-Swiss dental implant maker has issued misleading statements regarding the safety of its NobelDirect and NobelPerfect Nobel Biocare Website 2007 implants, Swiss Sunday paper SonntagsZeitung reported. Claim: History of Osseointegration (On 07.30.07, Heliane Canepa was replaced as CEO of Nobel Biocare) Using Non-integrated SEM The Swedish Medical Products Agency (SMPA) released a demand for Nobel Biocare to improve the instructions for both its NobelDirect and NobelPerfect Implants. Previously Nobel Biocare had released a response to the recent marketing ban on their NobelDirect Implant following reports that it lost an excessive amount of bone following placement. The SMPA stood by its decision that the firm not be allowed to market the implants until it had carried out the improvement of the instructions. The SMPA stated that the instructional information must be supplemented and further clarified. As an example, the SMPA described Nobel Biocare’s Instruction statement: “you don’t have to be a specialist to prepare the site for NobelDirect” as inappropriate. 3 et.al http://www.implantdirect.com/Pdf/USCourtofAppealsfortheFederalCircuit.pdf http://www.implantdirect.com/speaksout3.htm

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