OPTIBOND SOLO PLUS

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 Solo Plus.

Pre-market Notification Details

Device IDK990498
510k NumberK990498
Device Name:OPTIBOND SOLO PLUS
ClassificationAgent, Tooth Bonding, 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 CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-17
Decision Date1999-03-08
Summary:summary

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