510(k) K171007
K171007 is an FDA 510(k) premarket notification submitted by Carl Zeiss Suzhou Co., Ltd. for the device "Fluorescence Mode". The FDA issued a decision of Substantially Equivalent on May 3, 2018. The device falls under product code NBL (Light-Induced Fluorescence Caries Detector), a Class II device regulated under 21 CFR 872.1745. Carl Zeiss Suzhou Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2018
- Date Received
- April 4, 2017
- 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