510(k) K211813
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2021
- Date Received
- June 11, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cleanser, Root Canal
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type