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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K946307
Device Name CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE
Applicant
Confi-Dental Products Co.
416 S. Taylor Ave.
Louisville,  CO  80027
Applicant Contact SHARON A LUTTON
Correspondent
Confi-Dental Products Co.
416 S. Taylor Ave.
Louisville,  CO  80027
Correspondent Contact SHARON A LUTTON
Regulation Number872.3690
Classification Product Code
EBF  
Date Received12/28/1994
Decision Date 01/26/1995
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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