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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 K892893
Device Name SDI POLYCARBONATE CROWN, SCHEIN'S
Applicant
Svenska Dental Instruments AB
P.O. Box 1432
S-171 27 Solna
Sweden,  SE
Applicant Contact JANNIE WALKER
Correspondent
Svenska Dental Instruments AB
P.O. Box 1432
S-171 27 Solna
Sweden,  SE
Correspondent Contact JANNIE WALKER
Regulation Number872.3330
Classification Product Code
ELZ  
Date Received04/20/1989
Decision Date 06/06/1989
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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