510(k) K193264
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 2020
- Date Received
- November 26, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Air-Powered, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type