ADSEAL ROOT CANAL SEALER

Resin, Root Canal Filling

META BIOMED CO., LTD.

The following data is part of a premarket notification filed by Meta Biomed Co., Ltd. with the FDA for Adseal Root Canal Sealer.

Pre-market Notification Details

Device IDK042769
510k NumberK042769
Device Name:ADSEAL ROOT CANAL SEALER
ClassificationResin, Root Canal Filling
Applicant META BIOMED CO., LTD. 41-19, 77TH STREET Elmhurst,  NY  11373
ContactJenny Shon
CorrespondentNeil E Devine
ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids,  MI  49548
Product CodeKIF  
CFR Regulation Number872.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-10-05
Decision Date2004-11-24
Summary:summary

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