510(k) K182712
K182712 is an FDA 510(k) premarket notification submitted by Kaltenbach & Voigt GmbH for the device "DEXIS CariVu 3-in-1 by KaVo". The FDA issued a decision of Substantially Equivalent on November 23, 2019. The device falls under product code NTK (Light Transmission Caries Detector), a Class II device regulated under 21 CFR 872.1745. Kaltenbach & Voigt GmbH has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 2019
- Date Received
- September 27, 2018
- 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