Hero 1 Dental Implant System

GUDID 08809488217380

Hero 1 Dental Implant System/Fixture

KJMEDITECH.CO.,LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 08809488217380
• NIH Device Record Key: 3d6dd8cc-6053-47dc-a65a-eef106c4d1e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hero 1 Dental Implant System
• Version Model Number: MZF600130
• 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	08809488217380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121098

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 1 Dental Implant System]

• 08809488217458: Hero 1 Dental Implant System/Cover Screw
• 08809488217441: Hero 1 Dental Implant System/Cover Screw
• 08809488217434: Hero 1 Dental Implant System/Cover Screw
• 08809488217427: Hero 1 Dental Implant System/Mount Abutment &Screw
• 08809488217410: Hero 1 Dental Implant System/Mount Abutment &Screw
• 08809488217403: Hero 1 Dental Implant System/Mount Abutment &Screw
• 08809488217397: Hero 1 Dental Implant System/Fixture
• 08809488217380: Hero 1 Dental Implant System/Fixture
• 08809488217373: Hero 1 Dental Implant System/Fixture
• 08809488217366: Hero 1 Dental Implant System/Fixture
• 08809488217359: Hero 1 Dental Implant System/Fixture
• 08809488217342: Hero 1 Dental Implant System/Fixture
• 08809488217335: Hero 1 Dental Implant System/Fixture
• 08809488217328: Hero 1 Dental Implant System/Fixture
• 08809488217311: Hero 1 Dental Implant System/Fixture
• 08809488217304: Hero 1 Dental Implant System/Fixture
• 08809488217298: Hero 1 Dental Implant System/Fixture
• 08809488217281: Hero 1 Dental Implant System/Fixture
• 08809488217274: Hero 1 Dental Implant System/Fixture
• 08809488217267: Hero 1 Dental Implant System/Fixture
• 08809488217250: Hero 1 Dental Implant System/Fixture
• 08809488217243: Hero 1 Dental Implant System/Fixture
• 08809488217236: Hero 1 Dental Implant System/Fixture
• 08809488217229: Hero 1 Dental Implant System/Fixture
• 08809488217212: Hero 1 Dental Implant System/Fixture
• 08809488217205: Hero 1 Dental Implant System/Fixture