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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Caries Detection
510(k) Number K955445
Device Name CARIES FINDER
Applicant
Danville Engineering, Inc.
1901 San Ramon Valley Blvd.
San Ramon,  CA  94583
Applicant Contact CRAIG R BRUNS
Correspondent
Danville Engineering, Inc.
1901 San Ramon Valley Blvd.
San Ramon,  CA  94583
Correspondent Contact CRAIG R BRUNS
Regulation Number872.1740
Classification Product Code
LFC  
Date Received11/29/1995
Decision Date 02/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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