Opera System®

GUDID 06970163081229

This is a 3D face scanner that works with the supplied software programs. By performing facial scanning directly, the scanner could acquire and save the 3D images of the face and the jaw movement tracking data, which can be used for the facial or the oral Computer-aided design (CAD).

Shining 3D Tech Co., Ltd.

Jaw physiology evaluation system

• Primary Device ID: 06970163081229
• NIH Device Record Key: 5b912f2c-1e1c-4179-9d71-0104702a03ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opera System®
• Version Model Number: MetiSmile
• 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	06970163081229 [Primary]

FDA Product Code

• NFS: Device, Jaw Tracking, For Monitoring Jaw Positions

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[06970163081229]

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[06970163081229]

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[06970163081229]

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[06970163081229]

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[06970163081229]

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[06970163081229]

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[06970163081229]

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[06970163081229]

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[06970163081229]

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-31
• Device Publish Date: 2023-08-23

On-Brand Devices [Opera System®]

• 06970163082691: The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t
• 06970163080512: The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t
• 06970163085135: The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t
• 06970163081229: This is a 3D face scanner that works with the supplied software programs. By performing facial s
• 06970163082103: The scanner is used to scan and capture the 3D characteristics of dental models including plaste