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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 K852745
Device Name PORCELAIN VENEER SYSTEM BONDING KIT
Applicant
The S. S. White Co.
P.O. Box 100
Holmdel,  NJ  07733
Applicant Contact JOSEPH J BUTLER
Correspondent
The S. S. White Co.
P.O. Box 100
Holmdel,  NJ  07733
Correspondent Contact JOSEPH J BUTLER
Regulation Number872.3690
Classification Product Code
EBF  
Date Received06/27/1985
Decision Date 08/16/1985
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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