LOTA SLA Dental Implant System and LOTA HA Dental Implant System

GUDID 08800118795148

LOTA SLA, LOTA HA Dental Implant System -Abutment

KJMEDITECH.CO.,LTD

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800118795148
• NIH Device Record Key: e7021062-57b0-4a6e-932c-66b8e2df35c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOTA SLA Dental Implant System and LOTA HA Dental Implant System
• Version Model Number: LTSA20506S1HB
• 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	08800118795148 [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

[08800118795148]

Moist Heat or Steam Sterilization

[08800118795148]

Moist Heat or Steam Sterilization

[08800118795148]

Moist Heat or Steam Sterilization

[08800118795148]

Moist Heat or Steam Sterilization

[08800118795148]

Moist Heat or Steam Sterilization

[08800118795148]

Moist Heat or Steam Sterilization

[08800118795148]

Moist Heat or Steam Sterilization

[08800118795148]

Moist Heat or Steam Sterilization

[08800118795148]

Moist Heat or Steam Sterilization

[08800118795148]

Moist Heat or Steam Sterilization

[08800118795148]

Moist Heat or Steam Sterilization

[08800118795148]

Moist Heat or Steam Sterilization

[08800118795148]

Moist Heat or Steam Sterilization

[08800118795148]

Moist Heat or Steam Sterilization

[08800118795148]

Moist Heat or Steam Sterilization

[08800118795148]

Moist Heat or Steam Sterilization

[08800118795148]

Moist Heat or Steam Sterilization

[08800118795148]

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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