510(k) K111465
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2012
- Date Received
- May 26, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instruments, Dental Hand
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type