LOTA SLA Dental Implant System and LOTA HA Dental Implant System

GUDID 08800118795179

LOTA SLA, LOTA HA Dental Implant System -Abutment

KJMEDITECH.CO.,LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800118795179
• NIH Device Record Key: 4fa5b652-abb2-4aee-9d79-4c8d1f546736
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOTA SLA Dental Implant System and LOTA HA Dental Implant System
• Version Model Number: LTSA20506S2HB
• 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	08800118795179 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202046

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800118795179]

Moist Heat or Steam Sterilization

[08800118795179]

Moist Heat or Steam Sterilization

[08800118795179]

Moist Heat or Steam Sterilization

[08800118795179]

Moist Heat or Steam Sterilization

[08800118795179]

Moist Heat or Steam Sterilization

[08800118795179]

Moist Heat or Steam Sterilization

[08800118795179]

Moist Heat or Steam Sterilization

[08800118795179]

Moist Heat or Steam Sterilization

[08800118795179]

Moist Heat or Steam Sterilization

[08800118795179]

Moist Heat or Steam Sterilization

[08800118795179]

Moist Heat or Steam Sterilization

[08800118795179]

Moist Heat or Steam Sterilization

[08800118795179]

Moist Heat or Steam Sterilization

[08800118795179]

Moist Heat or Steam Sterilization

[08800118795179]

Moist Heat or Steam Sterilization

[08800118795179]

Moist Heat or Steam Sterilization

[08800118795179]

Moist Heat or Steam Sterilization

[08800118795179]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-30
• Device Publish Date: 2023-06-22

On-Brand Devices [LOTA SLA Dental Implant System and LOTA HA Dental Implant System]

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