Nobel Biocare has released a response to the recent marketing ban in their NobelDirect implant following reports that it lost an excessive amount of bone following placement. The response called the initial report to the Swedish Medical Products Agency (SMPA) on NobelDirect by Dr Albrektsson as `… incomplete and reported in an unscientific way. The analysis of the present manuscript shows that the material still suffers from intransparency and lack of scientific stringency. The process for peer-review may even be
Implant Design
Trinon`s Short Q-Implant
Trinon has designed a series of extremely short, but wide implants designed for use in areas of limited alveolar height. This design is appropriate for severely atrophied, but wide lower and upper jaw architectures. Insertion is via trephine use and are very appropriate for internal sinus lift use. The implants range in size from 4mm to 7mm in height.
Straumann Receives Patent on New Mounting System
Straumann has been granted a US Patent on its new implant delivery mount. The much needed redesign features `keyless` removal and incorporates an innovative implant indexing system into the mount, anticipating that implant indexing will increasingly be done at the time of implant placement.
Ceraroot`s newest Zirconium Implant – Google Surgical Video
Ceraroot which makes various anatomically shaped single piece zirconium implants has released another `extraction and immediate implant` video on Google video. This one features a maxillary pre-molar.
Biomet / 3i launches Nanotite Implant
Biomet / 3i has released their upgraded surface, Nanotite. Nanotite features their previous Osseotite surface treated with discrete crystalline deposition of Calcium Phosphate (CaP) resulting in a more complex surface topography. They claim that the biologic benefits Of CaP may play a key role in enhanced site response, potentially improving clinical predictability and outcomes. – This surface is named the same as one released by Bicon a few months ago, are they the same?
Drug Delivering Prosthetic Implant
The Fraunhofer Institute for Biomedical Engineering IBMT in Germany have developed a dental prosthesis consisting of a drug-filled reservoir, a valve, two sensors and several electronic components. Saliva enters the reservoir via a membrane, dissolves part of the solid drug and flows through a small duct into the mouth cavity, where it is absorbed by the mucous membranes in the patient’s cheeks. The duct is fitted with two sensors that monitor the amount of medicine being released into the body.
Sweden`s MPA restricts sale of NobelDirect and NobelPerfect
The Swedish Medical Products Agency investigation of the dental implants NobelDirect and NobelPerfect show that there can be deficiencies in the instructions for use for the products.The MPA decision directs Nobel Biocare to clearly describe possible causes for the breakdown of the jawbone in the instructions for use and training programs. In addition, the company must describe how the risk for breakdown can be avoided. In sales and promotion information and instructions for use, the company shall indicate the user
Nobel Direct – too risky to use except with `great care`
Sweden`s Medical Products Agency has made a preliminary finding that Nobel Biocare AG`s dental implant Nobel Direct, is too risky to use except with `great care`. The regulator said it will over the next few weeks come to a final view on Nobel Direct and what eventual warnings will be attached to the implant. The agency issued its statement after investigating the results of Nobel Biocare`s own two year study and said this study was not based on a representative
Implant Direct – Dr Niznick Returns
Implant Direct LLC has received a FDA 510(K) Marketing Clearance for their Spectra System. Dr Niznick, inventor of the internal anti-rotational connection, has started his own dental implant design and manufacturing company that employs a web-based order and support model to deliver a versatile line of implants at about 50% of the price of the major manufacturers.
NobelDirect – Verdict delayed
Sweden`s Medical Product Agency (SMPA) has announced it will delay its final verdict on the safety of Nobel Biocare AB`s dental implant NobelDirect, which is alleged to cause bone-loss, until November. The agency cited a delay in the release of Nobel Biocare`s two-year follow-up study as being responsible. Two Swedish dentists in May 2005 alleged that the product is causing bone-loss, prompting investigations by the heathcare authority.