SMARTDent

GUDID 08800003005017

Ray Co., Ltd

Dental treatment application software

• Primary Device ID: 08800003005017
• NIH Device Record Key: 16bbaadb-d773-4323-b1da-dccc48a4aff2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTDent
• Version Model Number: 3.1.0.0
• 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	08800003005017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251109

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: 2025-06-05
• Device Publish Date: 2025-05-28

Devices Manufactured by Ray Co., Ltd

• 08800003005017 - SMARTDent: 2025-06-05
• 08800003005017 - SMARTDent: 2025-06-05
• 08800003027064 - RCT600: 2025-04-22
• 08800003027071 - RCT600: 2025-04-22
• 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