iTero Element 5D— 510(k) K193659

Substantially Equivalent

Align Technology, Inc.

FDA 510(k) clearance K193659 for iTero Element 5D, Substantially Equivalent on 2020-03-20. Applicant: Align Technology, Inc.. Device class: 2.

Clearance details

Applicant: Align Technology, Inc.
Product code: Code NTK
Device class: Class 2
Regulation: 21 CFR 872.1745
Advisory panel: Dental
Date received: 2019-12-30
Decision date: 2020-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.