J2E Implant System

GUDID 08809488219377

J2E Implant System/Abutment

KJMEDITECH.CO.,LTD

Dental implant suprastructure, permanent, preformed
Primary Device ID08809488219377
NIH Device Record Key7374d20b-7d2e-4ce8-84aa-b5f395e367eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameJ2E Implant System
Version Model NumberCW603040NH
Company DUNS688476027
Company NameKJMEDITECH.CO.,LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809488219377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809488219377]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-19
Device Publish Date2019-11-11

On-Brand Devices [J2E Implant System ]

08809488219469J2E Implant System/Abutment
08809488219452J2E Implant System/Abutment
08809488219445J2E Implant System/Abutment
08809488219438J2E Implant System/Abutment
08809488219421J2E Implant System/Abutment
08809488219414J2E Implant System/Abutment
08809488219407J2E Implant System/Abutment
08809488219391J2E Implant System/Abutment
08809488219384J2E Implant System/Abutment
08809488219377J2E Implant System/Abutment
08809488219360J2E Implant System/Abutment
08809488219353J2E Implant System/Abutment
08809488219346J2E Implant System/Abutment
08809488219339J2E Implant System/Abutment
08809488219322J2E Implant System/Abutment
08809488219315J2E Implant System/Abutment
08809488219308J2E Implant System/Abutment
08809488219292J2E Implant System/Abutment
08809488219285J2E Implant System/Abutment
08809488219278J2E Implant System/Abutment
08809488219261J2E Implant System/Abutment
08809488219254J2E Implant System/Abutment
08809488219247J2E Implant System/Abutment
08809488219230J2E Implant System/Abutment
08809488219223J2E Implant System/Abutment
08809488219216J2E Implant System/Abutment
08809488219209J2E Implant System/Abutment
08809488219193J2E Implant System/Abutment
08809488219186J2E Implant System/Abutment
08809488219179J2E Implant System/Abutment
08809488219162J2E Implant System/Abutment
08809488219155J2E Implant System/Abutment
08809488219148J2E Implant System/Abutment
08809488219131J2E Implant System/Abutment
08809488219124J2E Implant System/Abutment
08809488219117J2E Implant System/Abutment
08809488219100J2E Implant System/Abutment
08809488219094J2E Implant System/Abutment
08809488219087J2E Implant System/Abutment
08809488219070J2E Implant System/Abutment
08809488219063J2E Implant System/Abutment
08809488219056J2E Implant System/Abutment
08809488219049J2E Implant System/Abutment
08809488219032J2E Implant System/Abutment
08809488219025J2E Implant System/Abutment
08809488219018J2E Implant System/Abutment
08809488219001J2E Implant System/Abutment
08809488218998J2E Implant System/Abutment
08809488218974J2E Implant System/Abutment
08809488218967J2E Implant System/Abutment

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