OPTIBOND-D

Agent, Tooth Bonding, Resin

SYBRON DENTAL SPECIALTIES, INC.

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

Pre-market Notification Details

Device IDK943738
510k NumberK943738
Device Name:OPTIBOND-D
ClassificationAgent, Tooth Bonding, Resin
Applicant SYBRON DENTAL SPECIALTIES, INC. 1332 SOUTH LONE HILL AVE. Glendora,  CA  91740
ContactJeffrey A Anderson
CorrespondentJeffrey A Anderson
SYBRON DENTAL SPECIALTIES, INC. 1332 SOUTH LONE HILL AVE. Glendora,  CA  91740
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-02
Decision Date1994-09-09

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