Magicore R

GUDID 08800039304474

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

Dental implant system

• Primary Device ID: 08800039304474
• NIH Device Record Key: ca8c1d40-08bf-420e-a1f5-905717142482
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magicore R
• Version Model Number: 553M6511
• 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	08800039304474 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152520

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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: 2018-11-26

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

• 08800039314084 - Magicore: 2024-10-30
• 08800039314169 - Magicore: 2024-10-30
• 08800039314176 - Magicore: 2024-10-30
• 08800039314183 - Magicore: 2024-10-30
• 08800039314268 - Magicore: 2024-10-30
• 08800039314275 - Magicore: 2024-10-30
• 08800039314282 - Magicore: 2024-10-30
• 08800039314367 - Magicore: 2024-10-30