AMII Implant Healing Cap Screw

GUDID 08809986619693

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

Dental implant system

• Primary Device ID: 08809986619693
• NIH Device Record Key: 2e6e1630-e0d0-4019-8b71-89814295ba53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMII Implant Healing Cap Screw
• Version Model Number: MDHCS4002
• 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: 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	08809986619693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212517

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

[08809986619693]

Moist Heat or Steam Sterilization

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

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

• 08800039381857 - Magic Depth Drill: 2025-09-03
• 08800039381871 - Magic Depth Drill: 2025-09-03
• 08800039381888 - Magic Depth Drill: 2025-09-03
• 08800177332582 - Magicore S: 2025-09-03
• 08800039307802 - Guide Drill: 2025-09-01
• 08800039307819 - Magic Depth Drill: 2025-09-01
• 08800039307826 - Magic Depth Drill: 2025-09-01
• 08800039307864 - Guide Drill: 2025-09-01