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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Fluorescence Caries Detection
510(k) Number K170822
Device Name Electronic Caries Detector
Applicant
Ortek Therapeutics, Inc.
4 Expressway Plaza
Roslyn Heights,  NY  11577
Applicant Contact Mitchell Goldberg
Correspondent
Acknowledge Regulatory Strategies
2834 Hawthorn St.
San Diego,  CA  92104
Correspondent Contact Allison Komiyama
Regulation Number872.1745
Classification Product Code
NBL  
Subsequent Product Code
LFC  
Date Received03/20/2017
Decision Date 09/11/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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