LEE ENDOFILL, ROOT CANAL FILLING RESIN

Resin, Root Canal Filling

LEE PHARMACEUTICALS

The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Lee Endofill, Root Canal Filling Resin.

Pre-market Notification Details

Device IDK810923
510k NumberK810923
Device Name:LEE ENDOFILL, ROOT CANAL FILLING RESIN
ClassificationResin, Root Canal Filling
Applicant LEE PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKIF  
CFR Regulation Number872.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-04-06
Decision Date1981-04-21

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