510(k) K190059
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 2019
- Date Received
- January 11, 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