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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K965083
Device Name SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET
Applicant
S.S. White Mfg., Ltd.
Unit 9, Madleaze Estate
Bristol Rd.
Gloucester,  GB GL1 5SG
Applicant Contact HUGH SAVELL
Correspondent
S.S. White Mfg., Ltd.
Unit 9, Madleaze Estate
Bristol Rd.
Gloucester,  GB GL1 5SG
Correspondent Contact HUGH SAVELL
Regulation Number872.3660
Classification Product Code
ELW  
Date Received12/19/1996
Decision Date 04/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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