IR Type Implant System

Implant, Endosseous, Root-form

Biotem Co., Ltd.

The following data is part of a premarket notification filed by Biotem Co., Ltd. with the FDA for Ir Type Implant System.

Pre-market Notification Details

Device IDK171185
510k NumberK171185
Device Name:IR Type Implant System
ClassificationImplant, Endosseous, Root-form
Applicant Biotem Co., Ltd. 57, Sasang-ro , 401 Beon-gil Sasang-gu Busan,  KR
ContactHong Koo Yeo
CorrespondentJoyce Bang
Provision Consulting Group Inc. 14071 Peyton Dr. #967 Chino Hills,  CA  91709
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-24
Decision Date2017-12-01
Summary:summary

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