Cleared Traditional

PROXEO Twist Cordless Polishing System PL-40 H

K201703 · W&H Dentalwerk Buermoos GmbH · Dental
Feb 2021
Decision
247d
Days
Class 1
Risk

About This 510(k) Submission

K201703 is an FDA 510(k) clearance for the PROXEO Twist Cordless Polishing System PL-40 H, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on February 24, 2021, 247 days after receiving the submission on June 22, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K201703 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2020
Decision Date February 24, 2021
Days to Decision 247 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKX — Handpiece, Direct Drive, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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