510(k) K183121
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 2019
- Date Received
- November 9, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type