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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K124025
Device Name ALPHA-PRO WHITE VARNISH
Applicant
Dental Technologies, Inc.
6901 N. Hamlin Ave.
Lincolnwood,  IL  60712
Applicant Contact PAULA ERICKSON
Correspondent
Dental Technologies, Inc.
6901 N. Hamlin Ave.
Lincolnwood,  IL  60712
Correspondent Contact PAULA ERICKSON
Regulation Number872.3260
Classification Product Code
LBH  
Date Received12/28/2012
Decision Date 09/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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