BIOROOT RCS

Resin, Root Canal Filling

NOVOCOL, INC.

The following data is part of a premarket notification filed by Novocol, Inc. with the FDA for Bioroot Rcs.

Pre-market Notification Details

Device IDK130601
510k NumberK130601
Device Name:BIOROOT RCS
ClassificationResin, Root Canal Filling
Applicant NOVOCOL, INC. 416 SOUTH TAYLOR AVE. Louisville,  CO  80027
ContactCora Bracho-troconis
CorrespondentCora Bracho-troconis
NOVOCOL, INC. 416 SOUTH TAYLOR AVE. Louisville,  CO  80027
Product CodeKIF  
CFR Regulation Number872.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-07
Decision Date2013-10-17
Summary:summary

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