Cleared Traditional

MASTERSURG / EXPERTSURG

K140308 · Kaltenbach & Voigt GmbH · Dental
Aug 2014
Decision
189d
Days
Class 1
Risk

About This 510(k) Submission

K140308 is an FDA 510(k) clearance for the MASTERSURG / EXPERTSURG, a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by Kaltenbach & Voigt GmbH (Biberach, DE). The FDA issued a Cleared decision on August 15, 2014, 189 days after receiving the submission on February 7, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K140308 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 2014
Decision Date August 15, 2014
Days to Decision 189 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBW — Controller, Foot, Handpiece And Cord
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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