510(k) K043156
K043156 is an FDA 510(k) premarket notification submitted by Neks Technologies, Inc. for the device "D-CARIE, MODEL N121-M1". The FDA issued a decision of Substantially Equivalent on April 28, 2005. 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
- April 28, 2005
- Date Received
- November 15, 2004
- 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