J2R Implant System

GUDID 08809488217977

J2R Implant System/Temporary Abutment

KJMEDITECH.CO.,LTD

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08809488217977
NIH Device Record Key320696d7-be44-4144-9cab-d27eb8293bd7
Commercial Distribution StatusIn Commercial Distribution
Brand NameJ2R Implant System
Version Model NumberJRTAW-NE
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
GS108809488217977 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809488217977]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-20
Device Publish Date2019-11-12

On-Brand Devices [J2R Implant System]

08809488218035J2R Implant System/Cover Screw
08809488218028J2R Implant System/Cover Screw
08809488218011J2R Implant System/Cover Screw
08809488218004J2R Implant System/Cover Screw
08809488217991J2R Implant System/Temporary Abutment
08809488217984J2R Implant System/Temporary Abutment
08809488217977J2R Implant System/Temporary Abutment
08809488217960J2R Implant System/Temporary Abutment
08809488217953J2R Implant System/Temporary Abutment
08809488217946J2R Implant System/Temporary Abutment
08809488217939J2R Implant System/Temporary Abutment
08809488217922J2R Implant System/Temporary Abutment
08809488217915J2R Implant System/Healing Abutment
08809488217908J2R Implant System/Healing Abutment
08809488217892J2R Implant System/Healing Abutment
08809488217885J2R Implant System/Healing Abutment
08809488217878J2R Implant System/Healing Abutment
08809488217861J2R Implant System/Healing Abutment
08809488217854J2R Implant System/Healing Abutment
08809488217847J2R Implant System/Healing Abutment
08809488217830J2R Implant System/Healing Abutment
08809488217823J2R Implant System/Healing Abutment
08809488217816J2R Implant System/Healing Abutment
08809488217809J2R Implant System/Healing Abutment
08809488217793J2R Implant System/Healing Abutment
08809488217786J2R Implant System/Healing Abutment
08809488217779J2R Implant System/EZ Abutment
08809488217762J2R Implant System/EZ Abutment
08809488217755J2R Implant System/EZ Abutment
08809488217748J2R Implant System/EZ Abutment
08809488217731J2R Implant System/EZ Abutment
08809488217724J2R Implant System/EZ Abutment
08809488217717J2R Implant System/EZ Abutment
08809488217700J2R Implant System/EZ Abutment
08809488217694J2R Implant System/Esthetic Abutment
08809488217687J2R Implant System/Esthetic Abutment
08809488217670J2R Implant System/Esthetic Abutment
08809488217663J2R Implant System/Esthetic Abutment
08809488217656J2R Implant System/Fixture
08809488217649J2R Implant System/Fixture
08809488217632J2R Implant System/Fixture
08809488217625J2R Implant System/Fixture
08809488217618J2R Implant System/Fixture
08809488217601J2R Implant System/Fixture
08809488217595J2R Implant System/Fixture
08809488217588J2R Implant System/Fixture
08809488217571J2R Implant System/Fixture
08809488217564J2R Implant System/Fixture
08809488217557J2R Implant System/Fixture
08809488217540J2R Implant System/Fixture

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