Cleared Traditional

K131319 - T1/T2/T3 TURBINE FAMILY

K131319 is the FDA 510(k) clearance for T1/T2/T3 TURBINE FAMILY by Sirona Dental Systems GmbH. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 388-day FDA review.

K131319 · Sirona Dental Systems GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
388d
Days
Class 1
Risk

K131319 is an FDA 510(k) clearance for the T1/T2/T3 TURBINE FAMILY. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on May 30, 2014 after a review of 388 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Sirona Dental Systems GmbH devices

Submission Details

510(k) Number K131319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
261d slower than avg
Panel avg: 127d · This submission: 388d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 77
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K131319.
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