THERMAFIL ENDODONTIC OBTURATOR

Gutta-percha

TULSA DENTAL PRODUCTS, LTD.

The following data is part of a premarket notification filed by Tulsa Dental Products, Ltd. with the FDA for Thermafil Endodontic Obturator.

Pre-market Notification Details

Device IDK881139
510k NumberK881139
Device Name:THERMAFIL ENDODONTIC OBTURATOR
ClassificationGutta-percha
Applicant TULSA DENTAL PRODUCTS, LTD. 5001 EAST 68TH ST. Tulsa,  OK  74136
ContactJohnson, Dds
CorrespondentJohnson, Dds
TULSA DENTAL PRODUCTS, LTD. 5001 EAST 68TH ST. Tulsa,  OK  74136
Product CodeEKM  
CFR Regulation Number872.3850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-17
Decision Date1988-04-07

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