510(k) K191133
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2019
- Date Received
- April 29, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- External Cleaning Solution
- Device Class
- Class II
- Regulation Number
- 872.3260
- Review Panel
- DE
- Submission Type
For use on dental restorations, external to the mouth, prior to insertion into the mouth.