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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K953504
Device Name MICROPRIME
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 Number872.3200
Classification Product Code
KLE  
Date Received07/26/1995
Decision Date 10/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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