510(k) K211701
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 2022
- Date Received
- June 3, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dental Navigation System
- Device Class
- Class II
- Regulation Number
- 872.4120
- Review Panel
- DE
- Submission Type
Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures.