Magicore Healing Cap

GUDID 08800039393584

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

Dental implant system

• Primary Device ID: 08800039393584
• NIH Device Record Key: abccac15-fe1b-4d37-ab42-b7a7633000b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magicore Healing Cap
• Version Model Number: MP CAP4.0L
• 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	08800039393584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220079
• Premarket Notification: K220517

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: 2023-01-12
• Device Publish Date: 2023-01-04

On-Brand Devices [Magicore Healing Cap]

• 08800177376968: MDHC6005B
• 08800177376951: MDHC6004B
• 08800177376944: MDHC6003B
• 08800177376937: MDHC6002B
• 08800177376920: MDHC6001B
• 08800177376913: MDHC5505B
• 08800177376906: MDHC5504B
• 08800177376890: MDHC5503B
• 08800177376883: MDHC5502B
• 08800177376876: MDHC5501B
• 08800177376869: MDHC5005B
• 08800177376852: MDHC5004B
• 08800177376845: MDHC5003B
• 08800177376838: MDHC5002B
• 08800177376821: MDHC5001B
• 08800177376814: MDHC4505B
• 08800177376807: MDHC4504B
• 08800177376791: MDHC4503B
• 08800177376784: MDHC4502B
• 08800177376777: MDHC4501B
• 08800177376760: MDHC6005
• 08800177376753: MDHC6004
• 08800177376746: MDHC6003
• 08800177376739: MDHC6002
• 08800177376722: MDHC6001
• 08800177376715: MDHC5005
• 08800177376708: MDHC5004
• 08800177376692: MDHC5003
• 08800177376685: MDHC5002
• 08800177376678: MDHC5001
• 08800090659667: MDHC5505
• 08800090659650: MDHC5504
• 08800090659643: MDHC5503
• 08800090659636: MDHC5502
• 08800090659629: MDHC5501
• 08800090659612: MDHC4505
• 08800090659605: MDHC4504
• 08800090659599: MDHC4503
• 08800090659582: MDHC4502
• 08800090659575: MDHC4501
• 08800039393584: MP CAP4.0L
• 08800039393577: MP CAP4.0S
• 08800039365178: MP CAP4.0