SHINING 3D®

GUDID 06970163085890

This is an intraoral scanner that works with the supplied software programs. By performing scanning directly and digitally acquiring and saving the 2D/3D color images of teeth, gingiva and oral mucosa, the scanner is available for patients with needs of orthodontic, implant, and restoration.

Shining 3D Tech Co., Ltd.

Dental milling system, CAD/CAM, chairside

• Primary Device ID: 06970163085890
• NIH Device Record Key: 1f20c884-7ef6-496a-a752-c399a8ddbdeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHINING 3D®
• Version Model Number: Aoralscan Elf (CG)
• 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	06970163085890 [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

[06970163085890]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970163085890]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970163085890]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970163085890]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970163085890]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970163085890]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970163085890]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970163085890]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970163085890]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970163085890]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970163085890]

Moist Heat or Steam Sterilization;High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-10
• Device Publish Date: 2025-09-02

On-Brand Devices [SHINING 3D®]

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• 06970163083797: Surgical Guide Resin SG01
• 06970163080390: The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t
• 06970163080833: The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t
• 06970163080192: This is a 3D face scanner that works with the supplied software programs. By performing facial s
• 06970163088013: This is a 3D face scanner that works with the supplied software programs. By performing facial s
• 06970163081878: The scanner is used to scan and capture the 3D characteristics of dental models including plaste
• 06970163082523: It is a part intended to obtain the exact implant position information to transfer it to the cor
• 06970163082516: It is a part intended to obtain the exact implant position information to transfer it to the cor
• 06970163082509: It is a part intended to obtain the exact implant position information to transfer it to the cor
• 06970163082486: It is a part intended to obtain the exact implant position information to transfer it to the cor
• 06970163082479: It is a part intended to obtain the exact implant position information to transfer it to the cor
• 06970163082462: It is a part intended to obtain the exact implant position information to transfer it to the cor
• 06970163082028: It is a part intended to obtain the exact implant position information to transfer it to the cor
• 06970163082011: It is a part intended to obtain the exact implant position information to transfer it to the cor
• 06970163081984: It is a part intended to obtain the exact implant position information to transfer it to the cor
• 06970163081977: It is a part intended to obtain the exact implant position information to transfer it to the cor
• 06970163081960: It is a part intended to obtain the exact implant position information to transfer it to the cor
• 06970163081946: It is a part intended to obtain the exact implant position information to transfer it to the cor
• 06970163081939: It is a part intended to obtain the exact implant position information to transfer it to the cor
• 06970163081922: It is a part intended to obtain the exact implant position information to transfer it to the cor
• 06970163081908: It is a part intended to obtain the exact implant position information to transfer it to the cor
• 06970163083032: The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t
• 06970163083100: Atip 3L
• 06970163083094: Atip 3S
• 06970163083056: Atip 3WL
• 06970163083063: Atip 3WS
• 06970163083711: Atip ES
• 06970163083704: Atip EL
• 06970163083667: Atip EB
• 06970163082110: The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t
• 06970163081342: The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t
• 06970163082622: Aoralscan Lync
• 06970163085715: HACS-A25-5(H)
• 06970163085708: HACS-A25-4(H)
• 06970163085692: HACS-A25-3(H)
• 06970163085685: HACS-A25-2(H)
• 06970163085661: HACS-A25-1(H)
• 06970163085654: HACS-A20-5(H)
• 06970163085647: HACS-A20-4(H)
• 06970163085630: HACS-A20-3(H)
• 06970163085623: HACS-A20-2(H)
• 06970163085616: HACS-A20-1(H)
• 06970163085609: HACS-A15-5(H)
• 06970163085586: HACS-A15-4(H)
• 06970163085579: HACS-A15-3(H)
• 06970163085562: HACS-A15-2(H)
• 06970163085548: HACS-A15-1(H)
• 06970163085531: HACS-A25-5(F)
• 06970163085524: HACS-A25-4(F)