Cleared Traditional

SMARTmatic

K163239 · Kaltenbach & Voigt GmbH · Dental
Mar 2017
Decision
119d
Days
Class 1
Risk

About This 510(k) Submission

K163239 is an FDA 510(k) clearance for the SMARTmatic, 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 March 17, 2017, 119 days after receiving the submission on November 18, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K163239 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2016
Decision Date March 17, 2017
Days to Decision 119 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