LOTA HA Dental Implant System

GUDID 08800075736741

LOTA HA Dental Implant System -Fixture

KJMEDITECH.CO.,LTD

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• Primary Device ID: 08800075736741
• NIH Device Record Key: 2826b08e-1427-443e-bd27-af9ffb196db8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOTA HA Dental Implant System
• Version Model Number: LOTA204013H
• 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	08800075736741 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202046

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: 2023-06-27
• Device Publish Date: 2023-06-19

On-Brand Devices [LOTA HA Dental Implant System]

• 08800075737359: LOTA HA Dental Implant System -Fixture
• 08800075737342: LOTA HA Dental Implant System -Fixture
• 08800075737335: LOTA HA Dental Implant System -Fixture
• 08800075737328: LOTA HA Dental Implant System -Fixture
• 08800075737311: LOTA HA Dental Implant System -Fixture
• 08800075737304: LOTA HA Dental Implant System -Fixture
• 08800075737298: LOTA HA Dental Implant System -Fixture
• 08800075737267: LOTA HA Dental Implant System -Fixture
• 08800075737250: LOTA HA Dental Implant System -Fixture
• 08800075737243: LOTA HA Dental Implant System -Fixture
• 08800075737236: LOTA HA Dental Implant System -Fixture
• 08800075737229: LOTA HA Dental Implant System -Fixture
• 08800075737212: LOTA HA Dental Implant System -Fixture
• 08800075737205: LOTA HA Dental Implant System -Fixture
• 08800075737175: LOTA HA Dental Implant System -Fixture
• 08800075737168: LOTA HA Dental Implant System -Fixture
• 08800075737151: LOTA HA Dental Implant System -Fixture
• 08800075737144: LOTA HA Dental Implant System -Fixture
• 08800075737137: LOTA HA Dental Implant System -Fixture
• 08800075737120: LOTA HA Dental Implant System -Fixture
• 08800075737113: LOTA HA Dental Implant System -Fixture
• 08800075737083: LOTA HA Dental Implant System -Fixture
• 08800075737076: LOTA HA Dental Implant System -Fixture
• 08800075737069: LOTA HA Dental Implant System -Fixture
• 08800075737052: LOTA HA Dental Implant System -Fixture
• 08800075737045: LOTA HA Dental Implant System -Fixture
• 08800075737038: LOTA HA Dental Implant System -Fixture
• 08800075737021: LOTA HA Dental Implant System -Fixture
• 08800075736994: LOTA HA Dental Implant System -Fixture
• 08800075736987: LOTA HA Dental Implant System -Fixture
• 08800075736970: LOTA HA Dental Implant System -Fixture
• 08800075736963: LOTA HA Dental Implant System -Fixture
• 08800075736956: LOTA HA Dental Implant System -Fixture
• 08800075736949: LOTA HA Dental Implant System -Fixture
• 08800075736932: LOTA HA Dental Implant System -Fixture
• 08800075736918: LOTA HA Dental Implant System -Fixture
• 08800075736901: LOTA HA Dental Implant System -Fixture
• 08800075736895: LOTA HA Dental Implant System -Fixture
• 08800075736888: LOTA HA Dental Implant System -Fixture
• 08800075736871: LOTA HA Dental Implant System -Fixture
• 08800075736864: LOTA HA Dental Implant System -Fixture
• 08800075736857: LOTA HA Dental Implant System -Fixture
• 08800075736833: LOTA HA Dental Implant System -Fixture
• 08800075736826: LOTA HA Dental Implant System -Fixture
• 08800075736819: LOTA HA Dental Implant System -Fixture
• 08800075736802: LOTA HA Dental Implant System -Fixture
• 08800075736796: LOTA HA Dental Implant System -Fixture
• 08800075736789: LOTA HA Dental Implant System -Fixture
• 08800075736772: LOTA HA Dental Implant System -Fixture
• 08800075736758: LOTA HA Dental Implant System -Fixture