RAYDENT SW

GUDID 08800003005031

Ray Co., Ltd

CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software

• Primary Device ID: 08800003005031
• NIH Device Record Key: df5052f6-0b75-417c-91f9-33bb69154beb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAYDENT SW
• Version Model Number: 2.2.0.0
• Company DUNS: 690324087
• Company Name: Ray 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800003005031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233625

FDA Product Code

• PNN: Orthodontic Software

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: 2024-05-31
• Device Publish Date: 2024-05-23

Devices Manufactured by Ray Co., Ltd

• 08800003005031 - RAYDENT SW: 2024-05-31
• 08800003005031 - RAYDENT SW: 2024-05-31
• 08800003000241 - RAYSCAN α-Expert: 2024-05-06
• 08800003000258 - RAYSCAN α-Expert: 2024-05-06
• 08800003000265 - RAYSCAN α-Expert: 2024-05-06
• 08800003000272 - RAYSCAN α-Expert: 2024-05-06
• 08800003000289 - RAYSCAN α-Expert: 2024-05-06
• 08800003000296 - RAYSCAN α-Expert: 2024-05-06
• 08800003000302 - RAYSCAN α-Expert: 2024-05-06