Cleared Traditional

MASTERmatic LUX

K143465 · Kaltenbach & Voigt GmbH · Dental
Apr 2015
Decision
126d
Days
Class 1
Risk

About This 510(k) Submission

K143465 is an FDA 510(k) clearance for the MASTERmatic LUX, a Handpiece, Belt And/or Gear Driven, Dental (Class I — General Controls, product code EFA), submitted by Kaltenbach & Voigt GmbH (Biberach, DE). The FDA issued a Cleared decision on April 9, 2015, 126 days after receiving the submission on December 4, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K143465 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2014
Decision Date April 09, 2015
Days to Decision 126 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFA — Handpiece, Belt And/or Gear Driven, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200