510(k) K261261
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2026
- Date Received
- April 16, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Crown And Bridge, Temporary, Resin
- Device Class
- Class II
- Regulation Number
- 872.3770
- Review Panel
- DE
- Submission Type