AeroPro Cordless Prophy System— 510(k) K180682

Name: FDA 510(k) clearance K180682
Creator: U.S. Food and Drug Administration
Published: 2019-02-27

Substantially Equivalent

Premier Dental Company Products

FDA 510(k) clearance K180682 for AeroPro Cordless Prophy System, Substantially Equivalent on 2019-02-27. Applicant: Premier Dental Company Products. Device class: 1.

Clearance details

Applicant: Premier Dental Company Products
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2018-03-15
Decision date: 2019-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth Meeting, PA, 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.