J2I Implant System

GUDID 08809488219735

J2I Implant System/Solid Abutment

KJMEDITECH.CO.,LTD

Dental implant suprastructure, permanent, preformed
Primary Device ID08809488219735
NIH Device Record Keyda3fb83d-0ecf-48db-88f6-75bbb6621a90
Commercial Distribution StatusIn Commercial Distribution
Brand NameJ2I Implant System
Version Model NumberISA6570
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
GS108809488219735 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809488219735]

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 [J2I Implant System]

08809488219797J2I Implant System/Two Piece Abutment
08809488219780J2I Implant System/Two Piece Abutment
08809488219773J2I Implant System/Two Piece Abutment
08809488219766J2I Implant System/Two Piece Abutment
08809488219759J2I Implant System/Two Piece Abutment
08809488219742J2I Implant System/Two Piece Abutment
08809488219735J2I Implant System/Solid Abutment
08809488219728J2I Implant System/Solid Abutment
08809488219711J2I Implant System/Solid Abutment
08809488219704J2I Implant System/Solid Abutment
08809488219698J2I Implant System/Solid Abutment
08809488219681J2I Implant System/Solid Abutment
08809488219674J2I Implant System/Cover Screw
08809488219667J2I Implant System/Cover Screw
08809488219650J2I Implant System/Fixture
08809488219643J2I Implant System/Fixture
08809488219636J2I Implant System/Fixture
08809488219629J2I Implant System/Fixture
08809488219612J2I Implant System/Fixture
08809488219605J2I Implant System/Fixture
08809488219599J2I Implant System/Fixture
08809488219582J2I Implant System/Fixture
08809488219575J2I Implant System/Fixture
08809488219568J2I Implant System/Fixture
08809488219551J2I Implant System/Fixture
08809488219544J2I Implant System/Fixture
08809488219537J2I Implant System/Fixture
08809488219520J2I Implant System/Fixture
08809488219513J2I Implant System/Fixture
08809488219506J2I Implant System/Fixture

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