ARi ExCon Implant ARIE385096M

GUDID 08809931182012

Megagen Implant Co. Ltd

Dental implant system

• Primary Device ID: 08809931182012
• NIH Device Record Key: 026fd0b0-3a25-43ec-a44f-6af0fd6c3deb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARi ExCon Implant
• Version Model Number: ARIE385096
• Catalog Number: ARIE385096M
• Company DUNS: 687388178
• Company Name: Megagen Implant Co. Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809931182012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231967

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: 2024-02-14
• Device Publish Date: 2024-02-06

On-Brand Devices [ARi ExCon Implant]

• 08809931182432: ARIE323596
• 08809931182425: ARIE323594
• 08809931182388: ARIE323576
• 08809931182371: ARIE323574
• 08809931182104: ARIE385596
• 08809931182098: ARIE385594
• 08809931182050: ARIE385576
• 08809931182043: ARIE385574
• 08809931182012: ARIE385096
• 08809931182005: ARIE385094
• 08809931181961: ARIE385076
• 08809931181954: ARIE385074
• 08809931181923: ARIE355096
• 08809931181916: ARIE355094
• 08809931181879: ARIE355076
• 08809931181862: ARIE355074
• 08809931181831: ARIE354596
• 08809931181824: ARIE354594
• 08809931181787: ARIE354576
• 08809931181770: ARIE354574
• 08809854028862: ARIE324596
• 08809854028855: ARIE324594
• 08809854028817: ARIE324576
• 08809854028800: ARIE324574
• 08809854028770: ARIE324096
• 08809854028763: ARIE324094
• 08809854028725: ARIE324076
• 08809854028718: ARIE324074
• 08809854028688: ARIE284096
• 08809854028671: ARIE284094
• 08809854028640: ARIE284076
• 08809854028619: ARIE283596
• 08809854028602: ARIE283594
• 08809854028572: ARIE283576
• 08809854028565: ARIE283574