ARi ExCon Implant ARIE354596M

GUDID 08809931181831

Megagen Implant Co. Ltd

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

• Primary Device ID: 08809931181831
• NIH Device Record Key: 3451b981-5214-4d66-a260-18286a8cc196
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARi ExCon Implant
• Version Model Number: ARIE354596
• Catalog Number: ARIE354596M
• 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	08809931181831 [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