Requirements and benefits of using and 510k Cleared Titanium customized abutment from an FDA approved facility
When it comes to 510(k) cleared titanium customized abutments, there is a bit of a fog of war. We at Creodent want to clear to the air so that Dental practitioners are better informed. Requirements according to the FDA:

  • Titanium Customized or Patient Specific Abutments are class II medical device is required to have 510(k) premarket clearance.
  • There are also no general clearance for dental implant abutment milling blanks.  Any company which is manufacturing or milling the dental implant to abutment interface should be registered and listed. 

Benefits of using a 510(k) cleared device

  • 510(k) cleared devices undergo rigorous 5 million cycle bench testing.
  • 8 Sets of detailed engineering drawings with statistical data, software validation as well as risk assessment.
  • All 510(k) cleared devices are manufactured by FDA registered facilities that are required to follow (GMP) Good Manufacturing Practices as well as being audited by the FDA for the proper implementation of a Quality Management system similar to ISO 9000.

Enforcement:

  • FDA has requested that any known none FDA approved milling center to get reported for their immediate investigation.

 

Why would you as Dental Practioners use an abutment that does not have proper clearance? Many laboratories or Milling center claim that they have 510(k) clearance but they will never be able to produce a 510k clearance number or a facility registration number under their name. You can easily search them out on the FDA website to verify.



Response from the FDA regarding this matter: