gudid
Primary ID: Detection Eye
Zirkonzahn (UDI Detection Eye)
Manufactured by Shining 3D Tech Co., Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Zirkonzahn - Primary ID Detection Eye
Device Regulatory Overview
The Zirkonzahn (Model/Catalog Number: Detection Eye) is a medical device manufactured by Shining 3D Tech Co., Ltd.. This product is indexed under FDA Product Code / Category Classification NOF within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Detection Eye
- Product Code / EMDN
- NOF
- Device Name
- 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.
- Database Sync Date
- 2026-08-09 09:05:22
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Zirkonzahn?
The registered manufacturer of record for Zirkonzahn is Shining 3D Tech Co., Ltd..
What is the Primary UDI-DI identifier for Zirkonzahn?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Detection Eye.
What classification code is assigned to this device?
This device is registered under product classification code NOF.
Similar Classification Devices (NOF)
Other Devices by Shining 3D Tech Co., Ltd.
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