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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown, Preformed
510(k) Number K932759
Device Name TEMPOARY POLYCARBONATE CROWNS
Applicant
South American Dental Exporting Corp.
1058 E. 33rd St.
Hialeah,  FL  33013
Applicant Contact LOPEZ
Correspondent
South American Dental Exporting Corp.
1058 E. 33rd St.
Hialeah,  FL  33013
Correspondent Contact LOPEZ
Regulation Number872.3330
Classification Product Code
ELZ  
Date Received06/08/1993
Decision Date 07/22/1994
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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