Cleared Traditional

T1/T2/T3 TURBINE FAMILY

K131319 · Sirona Dental Systems GmbH · Dental
May 2014
Decision
388d
Days
Class 1
Risk

About This 510(k) Submission

K131319 is an FDA 510(k) clearance for the T1/T2/T3 TURBINE FAMILY, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on May 30, 2014, 388 days after receiving the submission on May 7, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K131319 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2013
Decision Date May 30, 2014
Days to Decision 388 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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