LOTA SLA Dental Implant System and LOTA HA Dental Implant System

GUDID 08800120000278

LOTA SLA, LOTA HA Dental Implant System -Abutment

KJMEDITECH.CO.,LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800120000278
• NIH Device Record Key: 53d8df57-e42e-4e33-8442-b0d4469fc0e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOTA SLA Dental Implant System and LOTA HA Dental Implant System
• Version Model Number: LTSAR256511S4
• 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	08800120000278 [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

[08800120000278]

Moist Heat or Steam Sterilization

[08800120000278]

Moist Heat or Steam Sterilization

[08800120000278]

Moist Heat or Steam Sterilization

[08800120000278]

Moist Heat or Steam Sterilization

[08800120000278]

Moist Heat or Steam Sterilization

[08800120000278]

Moist Heat or Steam Sterilization

[08800120000278]

Moist Heat or Steam Sterilization

[08800120000278]

Moist Heat or Steam Sterilization

[08800120000278]

Moist Heat or Steam Sterilization

[08800120000278]

Moist Heat or Steam Sterilization

[08800120000278]

Moist Heat or Steam Sterilization

[08800120000278]

Moist Heat or Steam Sterilization

[08800120000278]

Moist Heat or Steam Sterilization

[08800120000278]

Moist Heat or Steam Sterilization

[08800120000278]

Moist Heat or Steam Sterilization

[08800120000278]

Moist Heat or Steam Sterilization

[08800120000278]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-03
• Device Publish Date: 2023-06-23

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

• 08800208629834: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118799351: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118799320: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118799290: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118799115: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118799085: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118799054: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118799023: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118798996: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118798781: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118798750: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118798729: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118798699: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118798484: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118798453: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118798422: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118798392: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118798217: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118798187: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118798156: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118798125: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118798095: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118797913: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118797883: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118797852: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118797821: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118797791: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118797616: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118797586: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118797555: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118797524: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118797494: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118797319: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118797289: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118797258: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118797227: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118797197: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118797012: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118796985: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118796954: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118796923: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118796893: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118796718: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118796688: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118796596: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118796411: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118796381: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118796350: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118796329: LOTA SLA, LOTA HA Dental Implant System -Abutment
• 08800118796299: LOTA SLA, LOTA HA Dental Implant System -Abutment