SHINING3D®

GUDID 06970163082684

Shining 3D Tech Co., Ltd.

Dental milling system, CAD/CAM, chairside

• Primary Device ID: 06970163082684
• NIH Device Record Key: a191a223-6ca2-41fd-bbc5-e31075ded3bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHINING3D®
• Version Model Number: Atip 3iWL
• 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	06970163082684 [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

[06970163082684]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082684]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082684]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082684]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082684]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082684]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082684]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082684]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082684]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082684]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082684]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082684]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082684]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082684]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082684]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082684]

High-level Disinfectant;Moist Heat or Steam Sterilization

[06970163082684]

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
• 06970163086026: The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t