Magicore

GUDID 08800039313278

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

Dental implant system

• Primary Device ID: 08800039313278
• NIH Device Record Key: 6addd706-3c36-4d73-9049-61b4c57998c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magicore
• Version Model Number: 602M5013
• 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: 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	08800039313278 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-25
• Device Publish Date: 2024-10-17

On-Brand Devices [Magicore]

• 08800039303705: 452M4013
• 08800039303699: 451M4013
• 08800039303682: 454M4011
• 08800039303675: 453M4011
• 08800039303668: 452M4011
• 08800039303651: 451M4011
• 08800039303644: 454M4009
• 08800039303637: 453M4009
• 08800039303620: 452M4009
• 08800039303606: 454M4007
• 08800039303590: 453M4007
• 08800039303583: 452M4007
• 08800039303576: 451M4007
• 08800039303880: 454M4513
• 08800039303873: 453M4513
• 08800039303859: 451M4513
• 08800039303842: 454M4511
• 08800039303835: 453M4511
• 08800039303828: 452M4511
• 08800039303811: 451M4511
• 08800039303804: 454M4509
• 08800039303798: 453M4509
• 08800039354943: 454M5009
• 08800039354936: 453M5009
• 08800039354929: 452M5009
• 08800039354912: 451M5009
• 08800039354721: 454M5007
• 08800039354714: 453M5007
• 08800039354707: 452M5007
• 08800039354691: 451M5007
• 08800039304030: 553M5013
• 08800039304023: 552M5013
• 08800039304016: 551M5013
• 08800039304009: 554M5011
• 08800039303972: 551M5011
• 08800039303958: 553M5009
• 08800039303941: 552M5009
• 08800039304528: 554M6513
• 08800039304511: 553M6513
• 08800039304504: 552M6513
• 08800039304498: 551M6513
• 08800039304481: 554M6511
• 08800039304467: 552M6511
• 08800039304450: 551M6511
• 08800039304436: 553M6509
• 08800039304429: 552M6509
• 08800039304412: 551M6509
• 08800039304405: 554M6507
• 08800039304399: 553M6507
• 08800039304382: 552M6507