R2i5

GUDID 08800293009726

Megagen Implant Co. Ltd

Intraoral optical scanning system

• Primary Device ID: 08800293009726
• NIH Device Record Key: f134bb1d-c749-452b-bb7d-642a00402e32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R2i5
• Version Model Number: 3DS Mega
• Company DUNS: 687388178
• Company Name: Megagen Implant Co. Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	08800293009726 [Primary]

FDA Product Code

• NOF: System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08800293009726]

Moist Heat or Steam Sterilization

[08800293009726]

Moist Heat or Steam Sterilization

[08800293009726]

Moist Heat or Steam Sterilization

[08800293009726]

Moist Heat or Steam Sterilization

[08800293009726]

Moist Heat or Steam Sterilization

[08800293009726]

Moist Heat or Steam Sterilization

[08800293009726]

Moist Heat or Steam Sterilization

[08800293009726]

Moist Heat or Steam Sterilization

[08800293009726]

Moist Heat or Steam Sterilization

[08800293009726]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-11
• Device Publish Date: 2025-12-03

Devices Manufactured by Megagen Implant Co. Ltd

• 08809985659300 - R2GATE Windows: 2026-04-01
• 08800292999219 - Hand Driver: 2026-03-30
• 08800292999226 - Hand Driver: 2026-03-30
• 08800292999233 - Hand Driver: 2026-03-30
• 08800292999240 - Hand Driver: 2026-03-30
• 08800292999257 - Removal Screw: 2026-03-30
• 08800292999264 - Screw Driver: 2026-03-30
• 08800292999271 - Screw Driver: 2026-03-30