510(k) K070854
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 2007
- Date Received
- March 28, 2007
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Agent, Polishing, Abrasive, Oral Cavity
- Device Class
- Class I
- Regulation Number
- 872.6030
- Review Panel
- DE
- Submission Type