Magicore R 554M6009

GUDID 08800039300759

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

Dental implant system

• Primary Device ID: 08800039300759
• NIH Device Record Key: 297eb66c-0120-4053-ab6e-a28a6c8e418d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magicore R 554M6009
• Version Model Number: Magicore R
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800039300759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152520

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-09-11
• Device Publish Date: 2018-10-08

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