Cleared Abbreviated

K013236 - LUXABITE

K013236 is an FDA 510(k) clearance for LUXABITE, manufactured by Dmg USA, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Abbreviated 510(k) pathway after a 19-day FDA review.

K013236 · Dmg USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
19d
Days
Class 2
Risk

K013236 is an FDA 510(k) clearance for the LUXABITE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on October 17, 2001 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dmg USA, Inc. devices

FDA 510(k) Submission Details - K013236

510(k) Number K013236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2001
Decision Date October 17, 2001
Days to Decision 19 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 127d · This submission: 19d
Pathway characteristics
Standards-based clearance path.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 325
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K013236.
S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL
K012767 · S & C Polymer GmbH · Nov 2001
XANTALGIN CRONO
K013336 · Cavex Holland BV · Oct 2001
STATUSBLUE
K013237 · Dmg USA, Inc. · Oct 2001
EXTRUDE MODIFIED
K012405 · Sybron Dental Specialties, Inc. · Sep 2001
CAVEX STABISIL
K011452 · Cavex Holland BV · Jul 2001
CAVEX COLORCHANGE
K011419 · Cavex Holland BV · Jul 2001