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..

Clearance details

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

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