510(k) K100854
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2010
- Date Received
- March 26, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Contra- And Right-Angle Attachment, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type