510(k) K212628
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 2022
- Date Received
- August 19, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Abutment, Implant, Dental, Endosseous
- Device Class
- Class II
- Regulation Number
- 872.3630
- Review Panel
- DE
- Submission Type
To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.