510(k) K063321
K063321 is an FDA 510(k) premarket notification submitted by Neks Technologies, Inc. for the device "D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138". The FDA issued a decision of Substantially Equivalent on March 30, 2007. The device falls under product code NBL (Light-Induced Fluorescence Caries Detector), a Class II device regulated under 21 CFR 872.1745. Neks Technologies, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2007
- Date Received
- November 2, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light-Induced Fluorescence Caries Detector
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type