J2E Implant System

GUDID 08809488218387

J2E Implant System/Fixture

KJMEDITECH.CO.,LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 08809488218387
• NIH Device Record Key: 32e01fa0-4474-40d9-935c-a594cdce96f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: J2E Implant System
• Version Model Number: JEF3816S
• 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: true
• 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	08809488218387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140051

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-22
• Device Publish Date: 2019-11-14

On-Brand Devices [J2E Implant System]

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