FDA 510K Cleared Titanium Custom Abutments

Several years ago we undertook the painstaking steps to implement an FDA style quality management system specifically designed for dental laboratories called DAMAS. With this in place, we were able to strategically partner with a Swiss company to become FDA Cleared as a Class II medical device manufacturer for milling titanium abutments. Our classification and special partnership bring a very high level of compliance, precision, and peace-of-mind.

Custom Abutment Blank / Digital Scan Body

Custom abutments have been a ROE standard for more than a decade. What does 510K Cleared mean for you? Doctors want options when restoring implants, with more versatility than stock parts. 510K Cleared means your abutments have been designed, milled, and inspected according to a strict protocol. Our partner ensures that the interface specs are within the original implant manufacturer’s guidelines, and ROE ensures the patient’s needs are meet with an anatomical abutment design.

510K clearance is unique for dental laboratories. There are a few milling centers in the USA with this status, but very few dental laboratories. With regard to timeliness, cost control, and quality, this solution provides our clients with significant advantages. Of course we do, and will continue to, provide OEM stock parts. Simply indicate your preference on the work authorization. If you have digital impressions and would like to transmit your cases to us digitally, precision $39 scan bodies are available for all popular systems. We also accept exchanges on other system’s scan bodies for a discounted trade-in price of $29 each.