BIOPURE MTAD ROOT CANAL CLEANSER

Cleanser, Root Canal

DENTSPLY INTL., INC.

The following data is part of a premarket notification filed by Dentsply Intl., Inc. with the FDA for Biopure Mtad Root Canal Cleanser.

Pre-market Notification Details

Device IDK053167
510k NumberK053167
Device Name:BIOPURE MTAD ROOT CANAL CLEANSER
ClassificationCleanser, Root Canal
Applicant DENTSPLY INTL., INC. SUSQUEHANNA COMMERCE CENTER 221W PHILADELPHIA ST. SUITE 60 York,  PA  17404
ContactHelen Lewis
CorrespondentHelen Lewis
DENTSPLY INTL., INC. SUSQUEHANNA COMMERCE CENTER 221W PHILADELPHIA ST. SUITE 60 York,  PA  17404
Product CodeKJJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2005-11-14
Decision Date2005-12-08
Summary:summary

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