Cleared Traditional

K092446 - INTRA LUX HEAD 3 LDSY

K092446 is an FDA 510(k) clearance for INTRA LUX HEAD 3 LDSY, manufactured by Kaltenbach & Voigt GmbH & Co.. The device is a Class 1 Dental device with product code EFA cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K092446 · Kaltenbach & Voigt GmbH & Co. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
85d
Days
Class 1
Risk

K092446 is an FDA 510(k) clearance for the INTRA LUX HEAD 3 LDSY. Classified as Handpiece, Belt And/or Gear Driven, Dental (product code EFA), Class I - General Controls.

Submitted by Kaltenbach & Voigt GmbH & Co. (Orange, US). The FDA issued a Cleared decision on November 3, 2009 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K092446

510(k) Number K092446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2009
Decision Date November 03, 2009
Days to Decision 85 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
43d faster than avg
Panel avg: 128d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

EFA Device Classification - Class 1, General Controls

Product Code EFA Handpiece, Belt And/or Gear Driven, 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 - EFA Handpiece, Belt And/or Gear Driven, Dental

All 22
Devices cleared under the same product code (EFA) and FDA review panel - the closest regulatory comparables to K092446.
MASTERmatic LUX
K143465 · Kaltenbach & Voigt GmbH · Apr 2015
RDT3 HANDPIECE HEAD MODEL RDT3
K101172 · Redent-Nova , Ltd. · Jul 2010
ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE
K093894 · Anthogyr · Mar 2010
LOW & HIGH SPEED KIT
K090055 · Dpm USA Corp. · Oct 2009
STRONG IMPLANT HANDPIECES
K092412 · Saeshin Precision Co., Ltd. · Sep 2009
MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES
K090676 · Anthogyr · May 2009
K092446 · INTRA LUX HEAD 3 LDSY
Download PDF FDA Summary Kaltenbach & Voigt Gm…