J2E Implant System

GUDID 08809488218332

J2E Implant System/Fixture

KJMEDITECH.CO.,LTD

Screw endosteal dental implant, two-piece
Primary Device ID08809488218332
NIH Device Record Keyce91a059-cfab-4082-b133-092811e51511
Commercial Distribution StatusIn Commercial Distribution
Brand NameJ2E Implant System
Version Model NumberJEF3318S
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809488218332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-22
Device Publish Date2019-11-14

On-Brand Devices [J2E Implant System]

08809488218981J2E Implant System/Abutment
08809488219490J2E Implant System/Cover Screw
08809488219483J2E Implant System/Cover Screw
08809488219476J2E Implant System/Cover Screw
08809488218660J2E Implant System/Fixture
08809488218653J2E Implant System/Fixture
08809488218646J2E Implant System/Fixture
08809488218639J2E Implant System/Fixture
08809488218622J2E Implant System/Fixture
08809488218615J2E Implant System/Fixture
08809488218608J2E Implant System/Fixture
08809488218592J2E Implant System/Fixture
08809488218585J2E Implant System/Fixture
08809488218578J2E Implant System/Fixture
08809488218561J2E Implant System/Fixture
08809488218554J2E Implant System/Fixture
08809488218547J2E Implant System/Fixture
08809488218530J2E Implant System/Fixture
08809488218523J2E Implant System/Fixture
08809488218516J2E Implant System/Fixture
08809488218509J2E Implant System/Fixture
08809488218493J2E Implant System/Fixture
08809488218486J2E Implant System/Fixture
08809488218479J2E Implant System/Fixture
08809488218462J2E Implant System/Fixture
08809488218455J2E Implant System/Fixture
08809488218448J2E Implant System/Fixture
08809488218431J2E Implant System/Fixture
08809488218424J2E Implant System/Fixture
08809488218417J2E Implant System/Fixture
08809488218400J2E Implant System/Fixture
08809488218394J2E Implant System/Fixture
08809488218387J2E Implant System/Fixture
08809488218370J2E Implant System/Fixture
08809488218363J2E Implant System/Fixture
08809488218356J2E Implant System/Fixture
08809488218349J2E Implant System/Fixture
08809488218332J2E Implant System/Fixture
08809488218325J2E Implant System/Fixture
08809488218318J2E Implant System/Fixture
08809488218301J2E Implant System/Fixture
08809488218295J2E Implant System/Fixture
08809488218288J2E Implant System/Fixture

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