Hero 2 & IS Dental Implant System

GUDID 08809488216741

Hero 2 & IS Dental Implant System/Fixture

KJMEDITECH.CO.,LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 08809488216741
• NIH Device Record Key: 70a662e1-bf5b-4e3e-a73e-cbb321805f9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hero 2 & IS Dental Implant System
• Version Model Number: MAF400150
• 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	08809488216741 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121047

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 [Hero 2 & IS Dental Implant System]

• 08809488217199: Hero 2 & IS Dental Implant System/Cover Screw
• 08809488217182: Hero 2 & IS Dental Implant System/Cover Screw
• 08809488217175: Hero 2 & IS Dental Implant System/Cover Screw
• 08809488217168: Hero 2 & IS Dental Implant System/Cover Screw
• 08809488217151: Hero 2 & IS Dental Implant System/Mount Abutment &Screw
• 08809488217144: Hero 2 & IS Dental Implant System/Mount Abutment &Screw
• 08809488217137: Hero 2 & IS Dental Implant System/Fixture
• 08809488217120: Hero 2 & IS Dental Implant System/Fixture
• 08809488217113: Hero 2 & IS Dental Implant System/Fixture
• 08809488217106: Hero 2 & IS Dental Implant System/Fixture
• 08809488217090: Hero 2 & IS Dental Implant System/Fixture
• 08809488217083: Hero 2 & IS Dental Implant System/Fixture
• 08809488217076: Hero 2 & IS Dental Implant System/Fixture
• 08809488217069: Hero 2 & IS Dental Implant System/Fixture
• 08809488217052: Hero 2 & IS Dental Implant System/Fixture
• 08809488217045: Hero 2 & IS Dental Implant System/Fixture
• 08809488217038: Hero 2 & IS Dental Implant System/Fixture
• 08809488217021: Hero 2 & IS Dental Implant System/Fixture
• 08809488217014: Hero 2 & IS Dental Implant System/Fixture
• 08809488217007: Hero 2 & IS Dental Implant System/Fixture
• 08809488216994: Hero 2 & IS Dental Implant System/Fixture
• 08809488216987: Hero 2 & IS Dental Implant System/Fixture
• 08809488216970: Hero 2 & IS Dental Implant System/Fixture
• 08809488216963: Hero 2 & IS Dental Implant System/Fixture
• 08809488216956: Hero 2 & IS Dental Implant System/Fixture
• 08809488216949: Hero 2 & IS Dental Implant System/Fixture
• 08809488216932: Hero 2 & IS Dental Implant System/Fixture
• 08809488216925: Hero 2 & IS Dental Implant System/Fixture
• 08809488216918: Hero 2 & IS Dental Implant System/Fixture
• 08809488216901: Hero 2 & IS Dental Implant System/Fixture
• 08809488216895: Hero 2 & IS Dental Implant System/Fixture
• 08809488216888: Hero 2 & IS Dental Implant System/Fixture
• 08809488216871: Hero 2 & IS Dental Implant System/Fixture
• 08809488216864: Hero 2 & IS Dental Implant System/Fixture
• 08809488216857: Hero 2 & IS Dental Implant System/Fixture
• 08809488216840: Hero 2 & IS Dental Implant System/Fixture
• 08809488216833: Hero 2 & IS Dental Implant System/Fixture
• 08809488216826: Hero 2 & IS Dental Implant System/Fixture
• 08809488216819: Hero 2 & IS Dental Implant System/Fixture
• 08809488216802: Hero 2 & IS Dental Implant System/Fixture
• 08809488216796: Hero 2 & IS Dental Implant System/Fixture
• 08809488216789: Hero 2 & IS Dental Implant System/Fixture
• 08809488216772: Hero 2 & IS Dental Implant System/Fixture
• 08809488216765: Hero 2 & IS Dental Implant System/Fixture
• 08809488216758: Hero 2 & IS Dental Implant System/Fixture
• 08809488216741: Hero 2 & IS Dental Implant System/Fixture
• 08809488216734: Hero 2 & IS Dental Implant System/Fixture
• 08809488216727: Hero 2 & IS Dental Implant System/Fixture
• 08809488216710: Hero 2 & IS Dental Implant System/Fixture
• 08809488216703: Hero 2 & IS Dental Implant System/Fixture