Premilled Titanium Block

GUDID 08800039372916

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

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system

• Primary Device ID: 08800039372916
• NIH Device Record Key: e4154a01-1439-40ce-9d1a-eeb0f8f19435
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premilled Titanium Block
• Version Model Number: FCH1020A
• 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: true
• 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	08800039372916 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203344

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800039372916]

Moist Heat or Steam Sterilization

[08800039372916]

Moist Heat or Steam Sterilization

[08800039372916]

Moist Heat or Steam Sterilization

[08800039372916]

Moist Heat or Steam Sterilization

[08800039372916]

Moist Heat or Steam Sterilization

[08800039372916]

Moist Heat or Steam Sterilization

[08800039372916]

Moist Heat or Steam Sterilization

[08800039372916]

Moist Heat or Steam Sterilization

[08800039372916]

Moist Heat or Steam Sterilization

[08800039372916]

Moist Heat or Steam Sterilization

[08800039372916]

Moist Heat or Steam Sterilization

[08800039372916]

Moist Heat or Steam Sterilization

[08800039372916]

Moist Heat or Steam Sterilization

[08800039372916]

Moist Heat or Steam Sterilization

[08800039372916]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-12
• Device Publish Date: 2022-09-02

Devices Manufactured by InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)

• 08809986603807 - Magic Guide Pin SET: 2024-02-02
• 08809986603814 - Magic Guide Pin SET: 2024-02-02
• 08809986603821 - Magic Guide Pin SET: 2024-02-02
• 08809986603838 - Magic Guide Pin SET: 2024-02-02
• 08809986603845 - Magic Guide Pin SET: 2024-02-02
• 08809986603852 - Magic Guide Pin SET: 2024-02-02
• 08809986603869 - Magic Guide Pin SET: 2024-02-02
• 08809986603876 - Magic Guide Pin SET: 2024-02-02