Magicore Solid Abutment

GUDID 08800039315425

InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)

Dental implant system

• Primary Device ID: 08800039315425
• NIH Device Record Key: 88d03bc7-71e7-4bae-a5e8-be9c587922cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magicore Solid Abutment
• Version Model Number: MA4506
• Company DUNS: 631169224
• Company Name: InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	08800039315425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201981

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[08800039315425]

Moist Heat or Steam Sterilization

[08800039315425]

Moist Heat or Steam Sterilization

[08800039315425]

Moist Heat or Steam Sterilization

[08800039315425]

Moist Heat or Steam Sterilization

[08800039315425]

Moist Heat or Steam Sterilization

[08800039315425]

Moist Heat or Steam Sterilization

[08800039315425]

Moist Heat or Steam Sterilization

[08800039315425]

Moist Heat or Steam Sterilization

[08800039315425]

Moist Heat or Steam Sterilization

[08800039315425]

Moist Heat or Steam Sterilization

[08800039315425]

Moist Heat or Steam Sterilization

[08800039315425]

Moist Heat or Steam Sterilization

[08800039315425]

Moist Heat or Steam Sterilization

[08800039315425]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-17
• Device Publish Date: 2020-09-09

On-Brand Devices [Magicore Solid Abutment]

• 08800039315463: MA5502
• 08800039315456: MA5006
• 08800039315449: MA5004
• 08800039315432: MA5002
• 08800039315425: MA4506
• 08800039315418: MA4504
• 08800039315401: MA4502
• 08800090659919: MA5005
• 08800090659902: MA5003
• 08800090659896: MA4505
• 08800090659889: MA4503
• 08800039315555: MA6006
• 08800039315548: MA6005
• 08800039315531: MA6004
• 08800039315524: MA6003
• 08800039315517: MA6002
• 08800039315500: MA5506
• 08800039315494: MA5505
• 08800039315487: MA5504
• 08800039315470: MA5503
• 08800039370301: MA4005
• 08800039370288: MA4003