PROFILE SERIES 29 FILES

File, Pulp Canal, Endodontic

TULSA DENTAL PRODUCTS, LTD.

The following data is part of a premarket notification filed by Tulsa Dental Products, Ltd. with the FDA for Profile Series 29 Files.

Pre-market Notification Details

Device IDK933582
510k NumberK933582
Device Name:PROFILE SERIES 29 FILES
ClassificationFile, Pulp Canal, Endodontic
Applicant TULSA DENTAL PRODUCTS, LTD. 5001 EAST 68TH ST. Tulsa,  OK  74136
ContactMike Bradford
CorrespondentMike Bradford
TULSA DENTAL PRODUCTS, LTD. 5001 EAST 68TH ST. Tulsa,  OK  74136
Product CodeEKS  
CFR Regulation Number872.4565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-23
Decision Date1993-10-20

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