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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K910803
Device Name ENAMEL ETCHING GEL
Applicant
Gresco Products, Inc.
12603 Executive Dr.
P.O. Box 865
Stafford,  TX  77477
Applicant Contact CLINTON D VAUPEL
Correspondent
Gresco Products, Inc.
12603 Executive Dr.
P.O. Box 865
Stafford,  TX  77477
Correspondent Contact CLINTON D VAUPEL
Regulation Number872.3750
Classification Product Code
DYH  
Date Received02/26/1991
Decision Date 03/15/1991
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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