iTero Element 2 Plus DOA Service Kit (UDI 00816063021070)
Manufactured by Align Technology Ltd.
Device Regulatory Overview
The iTero Element 2 Plus DOA Service Kit (Model/Catalog Number: 211789) 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
- 211789
- Product Code / EMDN
- Z110601
- Device Name
- iTero Element 2 family
- Database Sync Date
- 2026-08-09 17:50:27
Full Regulatory Attributes
đŸ”’ Token Gated
{
"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 2 Plus DOA Service Kit?
The registered manufacturer of record for iTero Element 2 Plus DOA Service Kit is Align Technology Ltd..
What is the Primary UDI-DI identifier for iTero Element 2 Plus DOA Service Kit?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00816063021070.
What classification code is assigned to this device?
This device is registered under product classification code Z110601.
Similar Classification Devices (Z110601)
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