Fluorescence Mode
FDA 510(k) K171007 · Carl Zeiss Suzhou Co., Ltd.
510(k) numberK171007
Submission
- Device name
- Fluorescence Mode
- Applicant
- Carl Zeiss Suzhou Co., Ltd.
Suzhou, CN - Received
- April 4, 2017
- Decision date
- May 3, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Fluorescence Mode cleared by the FDA?
Fluorescence Mode (K171007) received a 510(k) decision of Substantially Equivalent on May 3, 2018, 394 days after the submission was received.
What is the product code of K171007?
The FDA product code is NBL – Light-Induced Fluorescence Caries Detector , a Class II (moderate risk) device regulated under 21 CFR 872.1745.