Acid Etchant— 510(k) K172953

Substantially Equivalent

American Orthodontics

FDA 510(k) clearance K172953 for Acid Etchant, Substantially Equivalent on 2018-02-06. Applicant: American Orthodontics. Device class: 2.

Clearance details

Applicant: American Orthodontics
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2017-09-26
Decision date: 2018-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheboygan, WI, 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.