AnyRidge Internal Fixture [Free sample] M-FANIHX4010C

GUDID 08806388297252

AnyRidge Internal Implant System

Megagen Implant Co. Ltd

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806388297252
• NIH Device Record Key: 21a6ad2c-ec41-495a-93db-18788548acbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnyRidge Internal Fixture [Free sample]
• Version Model Number: FANIHX4010
• Catalog Number: M-FANIHX4010C
• 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	08806388297252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122231

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: 2023-11-16
• Device Publish Date: 2023-11-08

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