DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit

Agent, Tooth Bonding, Resin

Diadent Group International

The following data is part of a premarket notification filed by Diadent Group International with the FDA for Diaetch Economic Package Type A, Diatech Regular Package, Diaetch Refill Package Type A, Diaetch Intro Kit.

Pre-market Notification Details

Device IDK192273
510k NumberK192273
Device Name:DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit
ClassificationAgent, Tooth Bonding, Resin
Applicant Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongu-si,  KR 28161
ContactKab Sun Lee
CorrespondentKab Sun Lee
Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongu-si,  KR 28161
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-22
Decision Date2020-02-07

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