510(k) K003090
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2000
- Date Received
- October 3, 2000
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type