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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 K070191
Device Name ALPHA-CORE DC
Applicant
Dental Technologies, Inc.
6901 N. Hamlin Ave.
Lincolnwood,  IL  60712
Applicant Contact JANINE RAUHUT
Correspondent
Dental Technologies, Inc.
6901 N. Hamlin Ave.
Lincolnwood,  IL  60712
Correspondent Contact JANINE RAUHUT
Regulation Number872.3690
Classification Product Code
EBF  
Date Received01/22/2007
Decision Date 03/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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