XPEED AnyRidge Internal Implant System ARHM60704NT

GUDID 08806388289998

XPEED AnyRidge Internal Implant System (M1) M/ M6/ L7/ H=4/ Non-Hex

Megagen Implant Co. Ltd

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08806388289998
• NIH Device Record Key: c2d3d808-a459-4b3d-ae8e-353051008eaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XPEED AnyRidge Internal Implant System
• Version Model Number: ARHM60704N
• Catalog Number: ARHM60704NT
• Company DUNS: 687388178
• Company Name: Megagen Implant Co. Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	08806388289998 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210826

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

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: 2023-06-01
• Device Publish Date: 2023-05-24

Devices Manufactured by Megagen Implant Co. Ltd

• 08809985669873 - AXA Prosthetic Kit: 2024-12-12 XPEED AnyRidge Internal Implant System
• 08809708757597 - TiGEN Abutment: 2024-12-09
• 08809708757603 - TiGEN Abutment: 2024-12-09
• 08809708758334 - TiGEN Abutment: 2024-12-09
• 08809708758341 - TiGEN Abutment: 2024-12-09
• 08809822764617 - TiGEN Abutment: 2024-12-09
• 08809822764624 - TiGEN Abutment: 2024-12-09
• 08809822764631 - TiGEN Abutment: 2024-12-09