FDA Device Establishments · JSON-LD · Markdown

Align Technology, Ltd.

FEI 3009646999 · Manufacture Medical Device · Status: Active

FEI Number3009646999
Owner / OperatorAlign Technology, Inc. (#9035576)
Address1 Yitzhak Rabin Rd., Petach Tikva Central, 4925110, IL
Mandatory US AgentAlign Technology, Inc.
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)NOF
Regulation § (21 CFR)872.3661
Proprietary namesiTero Element 5D Plus Lite; iTero Element 2; iTero HDU Scanner; iTero Element 2 Plus Mobile; iTero Element Flex, Certified Pre-owned; iTero Element Flex; iOC Scanner; iTero Element, Certified Pre-owned; iTero Element; iTero Element 2 Plus

External sources

Source: openFDA. Public-domain (CC0).