SEALAPEX 4

Resin, Root Canal Filling

SYBRON DENTAL SPECIALTIES, INC.

The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Sealapex 4.

Pre-market Notification Details

Device IDK010940
510k NumberK010940
Device Name:SEALAPEX 4
ClassificationResin, Root Canal Filling
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 CodeKIF  
CFR Regulation Number872.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-29
Decision Date2001-06-20

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