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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 K925062
Device Name PERMAFLEX PERMANENT SOFT DENTURE RELINER
Applicant
Protech Professional Products, Inc.
12 Lynhaven Pl.
Centereach,  NY  11720
Applicant Contact BARRY BLOCH
Correspondent
Protech Professional Products, Inc.
12 Lynhaven Pl.
Centereach,  NY  11720
Correspondent Contact BARRY BLOCH
Regulation Number872.3760
Classification Product Code
EBI  
Date Received10/06/1992
Decision Date 03/31/1993
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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