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510(k) K171007

Fluorescence Mode by Carl Zeiss Suzhou Co., Ltd. — Product Code NBL

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
Laser, Fluorescence Caries Detection
Device Class
Class II
Regulation Number
872.1745
Review Panel
DE
Submission Type

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