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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diagnostic Light, Soft Tissue Detector
510(k) Number K073483
Device Name SAPPHIRE O/E ORAL EXAMINATION SYSTEM
Applicant
Den-Mat Holdings, LLC
2727 Skyway Dr.
Santa Maria,  CA  93455
Applicant Contact ALAN MATTHEWS
Correspondent
Den-Mat Holdings, LLC
2727 Skyway Dr.
Santa Maria,  CA  93455
Correspondent Contact ALAN MATTHEWS
Regulation Number872.6350
Classification Product Code
NXV  
Date Received12/11/2007
Decision Date 04/03/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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