R2GATE Windows

GUDID 08809985659300

Megagen Implant Co. Ltd

Dental treatment application software

• Primary Device ID: 08809985659300
• NIH Device Record Key: 735b798f-0d84-46e4-aedb-9d245e94e0c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R2GATE Windows
• Version Model Number: R2GATE
• 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: false
• Lot Batch: false
• Serial Number: false
• 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	08809985659300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190096

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-04-01
• Device Publish Date: 2026-03-24

Devices Manufactured by Megagen Implant Co. Ltd

• 08809985659300 - R2GATE Windows: 2026-04-01
• 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