510(k) K151748
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 2016
- Date Received
- June 29, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prophy Powder, Airbrush Accessory
- Device Class
- Class II
- Regulation Number
- 872.6080
- Review Panel
- DE
- Submission Type
An air polishing powder to be used with an airbrush for prophylaxis in the oral cavity.