MINERAL TRIOXIDE AGGREGATE (MTA)

Resin, Root Canal Filling

TULSA DENTAL PRODUCTS, LTD.

The following data is part of a premarket notification filed by Tulsa Dental Products, Ltd. with the FDA for Mineral Trioxide Aggregate (mta).

Pre-market Notification Details

Device IDK964174
510k NumberK964174
Device Name:MINERAL TRIOXIDE AGGREGATE (MTA)
ClassificationResin, Root Canal Filling
Applicant TULSA DENTAL PRODUCTS, LTD. 8309 BRYANT DR. Bethesda,  MD  20817
ContactH. N. Dunning
CorrespondentH. N. Dunning
TULSA DENTAL PRODUCTS, LTD. 8309 BRYANT DR. Bethesda,  MD  20817
Product CodeKIF  
CFR Regulation Number872.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-18
Decision Date1997-02-10
Summary:summary

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