510(k) K201856
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 2020
- Date Received
- July 6, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type