510(k) K193405
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 2020
- Date Received
- December 9, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Implant, Dental, Endosseous
- Device Class
- Class I
- Regulation Number
- 872.3980
- Review Panel
- DE
- Submission Type