Inside Dental Technology
July 2014, Volume 5, Issue 7
Published by AEGIS Communications
Solidex Titanium Customized Abutments
The next generation of FDA-approved milled titanium abutments
> Titanium-customized abutment restorations for major industry’s standard implant systems are not new. With so many inexpensive and low-quality milling machines entering the market, many small milling centers have opened in the past few years. This should be a concern for both dental laboratories that are purchasing these products as well as dentists. The U.S. Food and Drug Administration (FDA) regulates titanium-customized abutments as medical devices that require FDA 510(k) approval.
These requirements, according to the FDA, are:
• Titanium-customized or patient-specific abutments are Class II medical devices required to have FDA 510(k) premarket clearance.
• Dental implant abutment milling blanks have no general clearance. Any company that is manufacturing or milling the dental implant to abutment interface should be registered and listed.
Benefits of using a FDA 510(k)-approved device:
• Passing of rigorous 5-million-cycle bench testing.
• Detailed engineering drawings and reverse engineering drawings are required with statistical data to validate designs and fit tolerances.
• Manufactured by FDA-registered facilities that are required to follow Good Manufacturing Practices and are audited by the FDA for proper implementation of a quality management system similar to ISO 9000.
Solidex Quality Guarantee
In the event of implant breakage after Solidex is placed, Creodent will refund the cost of the implant fixture and replacement abutment if the original manufacturer of the implant voids the warranty. Please check Creodent’s website for more details at: http://creomc.com/solidex-quality-guarantee.
• Your fiduciary duty is to provide your dentist with legal restorations according to the FDA.
• Higher level of finish, quality, and constancy from an inspected and regulated milling center.
• Creo guarantee to alleviate issues with implant manufacturers that might have voided their warranties.
Disclaimer: The preceding material was provided by the manufacturer. The statements and opinions contained therein are solely those of the manufacturer and not of the editors, publisher, or the Editorial Board of Inside Dental Technology.
For more information, contact:
Creo Milling Center