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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K061735
Device Name INFIBRA, MODEL 1200
Applicant
Global Dental Products, Inc.
1028 Mclean Ave.
Wantagh,  NY  11793
Applicant Contact JERRY BARTICK
Correspondent
Global Dental Products, Inc.
1028 Mclean Ave.
Wantagh,  NY  11793
Correspondent Contact JERRY BARTICK
Regulation Number872.3760
Classification Product Code
EBI  
Date Received06/20/2006
Decision Date 09/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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