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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K964691
Device Name TCB TEMPORARY CROWN AND BRIDGE MATERIAL
Applicant
Scican
1440 Don Mills Rd.
Toronto,  CA M3B 3P9
Applicant Contact EVA YOUNG
Correspondent
Scican
1440 Don Mills Rd.
Toronto,  CA M3B 3P9
Correspondent Contact EVA YOUNG
Regulation Number872.3770
Classification Product Code
EBG  
Date Received11/22/1996
Decision Date 02/04/1997
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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