Magicore Healing Cap Screw

GUDID 08800177377095

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

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system

• Primary Device ID: 08800177377095
• NIH Device Record Key: ae2b937d-ea79-49c8-811a-e9cf5860e629
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magicore Healing Cap Screw
• Version Model Number: MDHCS5502
• 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 Safe
• 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	08800177377095 [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

[08800177377095]

Moist Heat or Steam Sterilization

[08800177377095]

Moist Heat or Steam Sterilization

[08800177377095]

Moist Heat or Steam Sterilization

[08800177377095]

Moist Heat or Steam Sterilization

[08800177377095]

Moist Heat or Steam Sterilization

[08800177377095]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-18
• Device Publish Date: 2022-05-10

On-Brand Devices [Magicore Healing Cap Screw]

• 08800177377163: MDHCS6005
• 08800177377156: MDHCS6004
• 08800177377149: MDHCS6003
• 08800177377132: MDHCS6002
• 08800177377125: MDHCS6001
• 08800177377118: MDHCS5505
• 08800177377101: MDHCS5504
• 08800177377095: MDHCS5502
• 08800177377088: MDHCS5503
• 08800177377071: MDHCS5501
• 08800177377064: MDHCS5005
• 08800177377057: MDHCS5004
• 08800177377040: MDHCS5003
• 08800177377033: MDHCS5002
• 08800177377026: MDHCS5001
• 08800177377019: MDHCS4505
• 08800177377002: MDHCS4504
• 08800177376999: MDHCS4503
• 08800177376982: MDHCS4502
• 08800177376975: MDHCS4501