510(k) K093894
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 3, 2010
- Date Received
- December 18, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Belt And/Or Gear Driven, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type