510(k) K231591
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2023
- Date Received
- June 1, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Crown And Bridge, Long-Term Temporary, Resin
- Device Class
- Class II
- Regulation Number
- 872.3770
- Review Panel
- DE
- Submission Type
For the fabrication of long-term temporary crowns and bridges