CORE1 Implant System

Implant, Endosseous, Root-form

Cybermed Inc.

The following data is part of a premarket notification filed by Cybermed Inc. with the FDA for Core1 Implant System.

Pre-market Notification Details

Device IDK210039
510k NumberK210039
Device Name:CORE1 Implant System
ClassificationImplant, Endosseous, Root-form
Applicant Cybermed Inc. 6-26, Yuseong-daero 1205 Beon-gil Yuseong-gu,  KR 34104
ContactHan Seul Kim
CorrespondentCheol Young Kim
Cybermed Inc. 6-26, Yuseong-daero 1205 Beon-gil Yuseong-gu,  KR 34104
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-06
Decision Date2022-01-07

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