J2E Implant System

GUDID 08809488219094

J2E Implant System/Abutment

KJMEDITECH.CO.,LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08809488219094
• NIH Device Record Key: 78a99a58-7c30-4393-989d-3bd455f9ab29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: J2E Implant System
• Version Model Number: CR503070NH
• 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	08809488219094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140051

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08809488219094]

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 [J2E Implant System ]

• 08809488219469: J2E Implant System/Abutment
• 08809488219452: J2E Implant System/Abutment
• 08809488219445: J2E Implant System/Abutment
• 08809488219438: J2E Implant System/Abutment
• 08809488219421: J2E Implant System/Abutment
• 08809488219414: J2E Implant System/Abutment
• 08809488219407: J2E Implant System/Abutment
• 08809488219391: J2E Implant System/Abutment
• 08809488219384: J2E Implant System/Abutment
• 08809488219377: J2E Implant System/Abutment
• 08809488219360: J2E Implant System/Abutment
• 08809488219353: J2E Implant System/Abutment
• 08809488219346: J2E Implant System/Abutment
• 08809488219339: J2E Implant System/Abutment
• 08809488219322: J2E Implant System/Abutment
• 08809488219315: J2E Implant System/Abutment
• 08809488219308: J2E Implant System/Abutment
• 08809488219292: J2E Implant System/Abutment
• 08809488219285: J2E Implant System/Abutment
• 08809488219278: J2E Implant System/Abutment
• 08809488219261: J2E Implant System/Abutment
• 08809488219254: J2E Implant System/Abutment
• 08809488219247: J2E Implant System/Abutment
• 08809488219230: J2E Implant System/Abutment
• 08809488219223: J2E Implant System/Abutment
• 08809488219216: J2E Implant System/Abutment
• 08809488219209: J2E Implant System/Abutment
• 08809488219193: J2E Implant System/Abutment
• 08809488219186: J2E Implant System/Abutment
• 08809488219179: J2E Implant System/Abutment
• 08809488219162: J2E Implant System/Abutment
• 08809488219155: J2E Implant System/Abutment
• 08809488219148: J2E Implant System/Abutment
• 08809488219131: J2E Implant System/Abutment
• 08809488219124: J2E Implant System/Abutment
• 08809488219117: J2E Implant System/Abutment
• 08809488219100: J2E Implant System/Abutment
• 08809488219094: J2E Implant System/Abutment
• 08809488219087: J2E Implant System/Abutment
• 08809488219070: J2E Implant System/Abutment
• 08809488219063: J2E Implant System/Abutment
• 08809488219056: J2E Implant System/Abutment
• 08809488219049: J2E Implant System/Abutment
• 08809488219032: J2E Implant System/Abutment
• 08809488219025: J2E Implant System/Abutment
• 08809488219018: J2E Implant System/Abutment
• 08809488219001: J2E Implant System/Abutment
• 08809488218998: J2E Implant System/Abutment
• 08809488218974: J2E Implant System/Abutment
• 08809488218967: J2E Implant System/Abutment