Cleared Traditional

K130560 - MASTERTORQUE LUX 8900 L

K130560 is the FDA 510(k) clearance for MASTERTORQUE LUX 8900 L by Kaltenbach & Voigt GmbH. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K130560 · Kaltenbach & Voigt GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
207d
Days
Class 1
Risk

K130560 is an FDA 510(k) clearance for the MASTERTORQUE LUX 8900 L. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Kaltenbach & Voigt GmbH (Biberach, DE). The FDA issued a Cleared decision on September 27, 2013 after a review of 207 days - an extended review cycle.

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. Standard predicate reliance. 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 Kaltenbach & Voigt GmbH devices

Submission Details

510(k) Number K130560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 127d · This submission: 207d
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 67
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K130560.
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K173465 · Dentalez, Inc. · Mar 2018
BOSWORTH AIR POLISHER
K100731 · Harry J. Bosworth Co. · Dec 2010
CENTURY MODEL 105C
K093341 · Sybron Dental Specialties, Inc. · Apr 2010
AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
K091065 · J. Morita USA, Inc. · Oct 2009