ICTmotor (WL-1)

Controller, Foot, Handpiece And Cord

Dentium Co., Ltd

The following data is part of a premarket notification filed by Dentium Co., Ltd with the FDA for Ictmotor (wl-1).

Pre-market Notification Details

Device IDK193341
510k NumberK193341
Device Name:ICTmotor (WL-1)
ClassificationController, Foot, Handpiece And Cord
Applicant Dentium Co., Ltd 76, Changnyong-daero 256beon-gil, Yeongtong-gu Suwon-si,  KR 16229
ContactSangwoo Lee
CorrespondentDave Kim
Mtech Group 7707 Fannin St. Ste 200, V111 Houston,  TX  77054
Product CodeEBW  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-03
Decision Date2020-09-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809460309843 K193341 000
08809460309843 K193341 000
08809460309843 K193341 000
08809460309843 K193341 000
08809460309843 K193341 000
08809460309843 K193341 000
08809460309843 K193341 000
08809460309843 K193341 000
08809460309843 K193341 000
08809460309843 K193341 000
08809460309843 K193341 000
08809460309843 K193341 000
08809460309843 K193341 000
08809460309843 K193341 000

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.