CORERESTORE 2

Material, Tooth Shade, Resin

SYBRON DENTAL SPECIALTIES, INC.

The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Corerestore 2.

Pre-market Notification Details

Device IDK011798
510k NumberK011798
Device Name:CORERESTORE 2
ClassificationMaterial, Tooth Shade, Resin
Applicant SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange,  CA  92867
ContactColleen Boswell
CorrespondentColleen Boswell
SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange,  CA  92867
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-08
Decision Date2001-08-14
Summary:summary

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