MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology— 510(k) K160825

Name: FDA 510(k) clearance K160825
Creator: U.S. Food and Drug Administration
Published: 2016-09-27

Substantially Equivalent

Dentsply Sirona

FDA 510(k) clearance K160825 for MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology, Substantially Equivalent on 2016-09-27. Applicant: Dentsply Sirona. Device class: 1.

Clearance details

Applicant: Dentsply Sirona
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2016-03-25
Decision date: 2016-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, 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.