eudamed_udi
Primary ID: 00816063021001
iTero Element™ 5D Plus (UDI 00816063021001)
Manufactured by Align Technology Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for iTero Element™ 5D Plus - Primary ID 00816063021001
Device Regulatory Overview
The iTero Element™ 5D Plus (Model/Catalog Number: 212260) is a medical device manufactured by Align Technology Ltd.. This product is indexed under FDA Product Code / Category Classification Z110601 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 212260
- Product Code / EMDN
- Z110601
- Device Name
- iTero Element 5D Family
- Database Sync Date
- 2026-08-09 17:14:02
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 iTero Element™ 5D Plus?
The registered manufacturer of record for iTero Element™ 5D Plus is Align Technology Ltd..
What is the Primary UDI-DI identifier for iTero Element™ 5D Plus?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00816063021001.
What classification code is assigned to this device?
This device is registered under product classification code Z110601.
Similar Classification Devices (Z110601)
Other Devices by Align Technology Ltd.
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