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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 K062683
Device Name ENAMEL PRO VARNISH
Applicant
PREMIER DENTAL PRODUCTS CO.
1710 ROMANO DR.
PLYMOUTH MEETING,  PA  19462
Applicant Contact VINCE D'ALESSANDRO
Correspondent
PREMIER DENTAL PRODUCTS CO.
1710 ROMANO DR.
PLYMOUTH MEETING,  PA  19462
Correspondent Contact VINCE D'ALESSANDRO
Regulation Number872.3260
Classification Product Code
LBH  
Date Received09/08/2006
Decision Date 11/21/2006
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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