BELLEGLASS HP OPACEOUS DENTIN

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 Belleglass Hp Opaceous Dentin.

Pre-market Notification Details

Device IDK000269
510k NumberK000269
Device Name:BELLEGLASS HP OPACEOUS DENTIN
ClassificationMaterial, Tooth Shade, Resin
Applicant SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange,  CA  92667
ContactColleen Boswell
CorrespondentColleen Boswell
SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange,  CA  92667
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-01-28
Decision Date2000-03-23

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