TDS Abutment

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K081460 ↗

FDA Product Code

NHA

Device Class

Class II

Regulation

21 CFR Part 872.3630

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Tds Abutment for Nobel Biocare Replace

  Class II

  FDA 510(k) K091026 Active Cleared 24 Jun 2009

• Tds Precision Dental Bar

  Class II

  FDA 510(k) K100356 Active Cleared 5 Oct 2010

• Tds Zirconia Abutment for Nobel Biocare Branemark

  Class II

  FDA 510(k) K091693 Active Cleared 30 Jul 2009

• Tds Abutment for Friadent Xive

  Class II

  FDA 510(k) K103339 Active Cleared 31 Mar 2011

• Tds Titanium Abutment for Nobel Biocare Branemark

  Class II

  FDA 510(k) K091392 Active Cleared 30 Jul 2009

• What is the TDS Abutment used for?

  The TDS Abutment serves as a connecting component between dental implants and prosthetic restorations specifically designed for use with Friadent Xive systems, providing a stable foundation for dental prostheses.

• Is the TDS Abutment reusable or single-use?

  The TDS Abutment is supplied as a single-use device and is not intended for reuse. This design ensures optimal performance and safety for each patient procedure.

• What regulatory approvals does the TDS Abutment have?

  The TDS Abutment is regulated under FDA 510(k) clearance with product code NHA and regulation number 872.3630. It has been determined substantially equivalent to predicate devices in indications and design principles.

• Is the TDS Abutment MRI safe?

  No, the TDS Abutment is not MRI safe. Patients should be informed of this limitation if they require MRI imaging procedures after implant placement.