510(k) K173163
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2018
- Date Received
- September 29, 2017
- Clearance Type
- Traditional
- 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