510(k) K212932
Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray by
Nobel Biocare Services AG
— Product Code KCT
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2021
- Date Received
- September 15, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device Class
- Class II
- Regulation Number
- 880.6850
- Review Panel
- HO
- Submission Type