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510(k) K170822

Electronic Caries Detector by Ortek Therapeutics, Inc. — Product Code NBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2017
Date Received
March 20, 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

Other clearances by Ortek Therapeutics, Inc.

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