510(k) K212538
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2021
- Date Received
- August 12, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type