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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K955337
Device Name OPAKER
Applicant
Kerr Dental Materials Center
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Applicant Contact LARRY WILLS
Correspondent
Kerr Dental Materials Center
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Correspondent Contact LARRY WILLS
Regulation Number872.3690
Classification Product Code
EBF  
Date Received11/21/1995
Decision Date 01/23/1996
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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