SOFT DENTURE REBASING RESIN

Resin, Denture, Relining, Repairing, Rebasing

SYBRON DENTAL SPECIALTIES, INC.

The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Soft Denture Rebasing Resin.

Pre-market Notification Details

Device IDK963736
510k NumberK963736
Device Name:SOFT DENTURE REBASING RESIN
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange,  CA  92867
ContactWilliam R Pike
CorrespondentWilliam R Pike
SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange,  CA  92867
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-17
Decision Date1996-12-04
Summary:summary

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