Cleared Traditional

MASTERTORQUE LUX 8900 L

K130560 · Kaltenbach & Voigt GmbH · Dental
Sep 2013
Decision
207d
Days
Class 1
Risk

About This 510(k) Submission

K130560 is an FDA 510(k) clearance for the MASTERTORQUE LUX 8900 L, 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 September 27, 2013, 207 days after receiving the submission on March 4, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K130560 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2013
Decision Date September 27, 2013
Days to Decision 207 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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