BELLEGLASS HP DC OPACEOUS DENTIN LCTE 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 Belleglass Hp Dc Opaceous Dentin Lcte 2.

Pre-market Notification Details

Device IDK013009
510k NumberK013009
Device Name:BELLEGLASS HP DC OPACEOUS DENTIN LCTE 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 Received2001-09-06
Decision Date2001-10-03
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.