Cleared Traditional

PROPHYflex 4

K181110 · Kaltenbach & Voigt GmbH · Dental
Apr 2019
Decision
348d
Days
Class 1
Risk

About This 510(k) Submission

K181110 is an FDA 510(k) clearance for the PROPHYflex 4, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Kaltenbach & Voigt GmbH (Biberach, DE). The FDA issued a Cleared decision on April 10, 2019, 348 days after receiving the submission on April 27, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K181110 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2018
Decision Date April 10, 2019
Days to Decision 348 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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