AMII Implant Closing Screw

GUDID 08809986609472

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

Dental implant system

• Primary Device ID: 08809986609472
• NIH Device Record Key: 52fb126f-162e-40ce-a9ba-0d1c280495c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMII Implant Closing Screw
• Version Model Number: HISCM
• 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: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	08809986609472 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202479

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-14
• Device Publish Date: 2025-08-06

On-Brand Devices [AMII Implant Closing Screw]

• 08809986609526: HISCP
• 08809986609519: HISCG
• 08809986609502: HISCB
• 08809986609496: HISCY
• 08809986609489: HISC07
• 08809986609472: HISCM
• 08809986609465: HISCS