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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 K852744
Device Name CHARACTERIZER KIT VISIBLE LIGHT CURED RESTOR-COLOR
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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