SHINING3D®

GUDID 06970163082707

Shining 3D Tech Co., Ltd.

Dental milling system, CAD/CAM, chairside

• Primary Device ID: 06970163082707
• NIH Device Record Key: 8e29a56d-b111-4cf1-b973-7799e12f4871
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHINING3D®
• Version Model Number: Atip 3iWS
• Company DUNS: 529835314
• Company Name: Shining 3D Tech 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970163082707 [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

[06970163082707]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082707]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082707]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082707]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082707]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082707]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082707]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082707]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082707]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082707]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082707]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082707]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082707]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082707]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082707]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082707]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082707]

High-level Disinfectant;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-01
• Device Publish Date: 2024-07-24

On-Brand Devices [SHINING3D®]

• 06970163082707: Atip 3iWS
• 06970163082684: Atip 3iWL