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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 K972027
Device Name ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)
Applicant
ZHERMACK S.P.A.
7527 WESTMORELAND AVE.
ST. LOUIS,  MO  63105
Applicant Contact EVAN DICK
Correspondent
ZHERMACK S.P.A.
7527 WESTMORELAND AVE.
ST. LOUIS,  MO  63105
Correspondent Contact EVAN DICK
Regulation Number872.3660
Classification Product Code
ELW  
Date Received06/02/1997
Decision Date 07/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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