Resin For Temporary Crown & Bridge

Crown And Bridge, Temporary, Resin

Dentis Co., Ltd.

The following data is part of a premarket notification filed by Dentis Co., Ltd. with the FDA for Resin For Temporary Crown & Bridge.

Pre-market Notification Details

Device IDK180657
510k NumberK180657
Device Name:Resin For Temporary Crown & Bridge
ClassificationCrown And Bridge, Temporary, Resin
Applicant Dentis Co., Ltd. 6, Yuram-ro, Dong-gu Daegu,  KR 41065
ContactDong-hun Jang
CorrespondentSoojung Moon
Allura Medical Solution Inc. 8141 Lampson Ave. #4 Garden Grove,  CA  92841
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-13
Decision Date2018-12-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806169157126 K180657 000

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