510(k) K062961
K062961 is an FDA 510(k) premarket notification submitted by Addent, Inc. for the device "MICROLUX TRANSILLUMINATOR". The FDA issued a decision of Substantially Equivalent on February 8, 2007. The device falls under product code NTK (Light Transmission Caries Detector), a Class II device regulated under 21 CFR 872.1745. Addent, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2007
- Date Received
- September 29, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Transmission Caries Detector
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type