510(k) K103244
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 2011
- Date Received
- November 2, 2010
- 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