PERMAFLEX PERMANENT SOFT DENTURE RELINER

Resin, Denture, Relining, Repairing, Rebasing

PROTECH PROFESSIONAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Protech Professional Products, Inc. with the FDA for Permaflex Permanent Soft Denture Reliner.

Pre-market Notification Details

Device IDK925062
510k NumberK925062
Device Name:PERMAFLEX PERMANENT SOFT DENTURE RELINER
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant PROTECH PROFESSIONAL PRODUCTS, INC. 12 LYNHAVEN PLACE Centereach,  NY  11720
ContactBarry Bloch
CorrespondentBarry Bloch
PROTECH PROFESSIONAL PRODUCTS, INC. 12 LYNHAVEN PLACE Centereach,  NY  11720
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-06
Decision Date1993-03-31

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