CCM Abutment System

Abutment, Implant, Dental, Endosseous

InnoBioSurg Co., Ltd.

The following data is part of a premarket notification filed by Innobiosurg Co., Ltd. with the FDA for Ccm Abutment System.

Pre-market Notification Details

Device IDK173120
510k NumberK173120
Device Name:CCM Abutment System
ClassificationAbutment, Implant, Dental, Endosseous
Applicant InnoBioSurg Co., Ltd. 44-19, Techno 10-ro, Yuseong-gu Daejeon,  KR 34027
ContactBo-reum Yoo
CorrespondentApril Lee
Withus Group Inc 2531 Pepperdale Drive Rowland Heights,  CA  91748
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-29
Decision Date2018-03-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800039379243 K173120 000
08800090660946 K173120 000
08800090660953 K173120 000
08800090660960 K173120 000
08800039303170 K173120 000
08800039303187 K173120 000
08800039364553 K173120 000
08800039364560 K173120 000
08800039364577 K173120 000
08800039364607 K173120 000
08800039364621 K173120 000
08800039379236 K173120 000
08800090660939 K173120 000

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