J2R Implant System

GUDID 08809488217489

J2R Implant System/Fixture

KJMEDITECH.CO.,LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 08809488217489
• NIH Device Record Key: fa6745ee-c7f6-4fe0-b42f-420fc0e02b88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: J2R Implant System
• Version Model Number: JRF3511
• 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	08809488217489 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130694

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: 2019-11-25
• Device Publish Date: 2019-11-15

On-Brand Devices [J2R Implant System]

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