J2I Implant System

GUDID 08809488219759

J2I Implant System/Two Piece Abutment

KJMEDITECH.CO.,LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08809488219759
• NIH Device Record Key: ae022ec4-cbf3-413c-80be-a13ae16a8b9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: J2I Implant System
• Version Model Number: ITPA4855
• Company DUNS: 688476027
• Company Name: KJMEDITECH.CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809488219759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140052

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08809488219759]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-19
• Device Publish Date: 2019-11-11

On-Brand Devices [J2I Implant System]

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