Zirkonzahn®

GUDID 06970163080635

The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired in the patient's mouth, and provides 3D digital models for CAD/CAM denture design and processing.

Shining 3D Tech Co., Ltd.

Dental milling system, CAD/CAM, chairside

• Primary Device ID: 06970163080635
• NIH Device Record Key: ee63e3ad-0a98-4b08-b5f1-3f4268ce9406
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zirkonzahn®
• Version Model Number: Detection Eye
• 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	06970163080635 [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

[06970163080635]

Moist Heat or Steam Sterilization

[06970163080635]

Moist Heat or Steam Sterilization

[06970163080635]

Moist Heat or Steam Sterilization

[06970163080635]

Moist Heat or Steam Sterilization

[06970163080635]

Moist Heat or Steam Sterilization

[06970163080635]

Moist Heat or Steam Sterilization

[06970163080635]

Moist Heat or Steam Sterilization

[06970163080635]

Moist Heat or Steam Sterilization

[06970163080635]

Moist Heat or Steam Sterilization

[06970163080635]

Moist Heat or Steam Sterilization

[06970163080635]

Moist Heat or Steam Sterilization

[06970163080635]

Moist Heat or Steam Sterilization

[06970163080635]

Moist Heat or Steam Sterilization

[06970163080635]

Moist Heat or Steam Sterilization

[06970163080635]

Moist Heat or Steam Sterilization

[06970163080635]

Moist Heat or Steam Sterilization

[06970163080635]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-08-24
• Device Publish Date: 2022-11-01

On-Brand Devices [Zirkonzahn®]

• 06970163085050: The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t
• 06970163080635: The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t