510(k) K112139
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 2012
- Date Received
- July 26, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Fluorescence Caries Detection
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type