Cleared Traditional

K012405 - EXTRUDE MODIFIED

K012405 is an FDA 510(k) clearance for EXTRUDE MODIFIED, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K012405 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
36d
Days
Class 2
Risk

K012405 is an FDA 510(k) clearance for the EXTRUDE MODIFIED. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on September 4, 2001 after a review of 36 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 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 - K012405

510(k) Number K012405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2001
Decision Date September 04, 2001
Days to Decision 36 days
Submission Type Traditional
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
92d faster than avg
Panel avg: 128d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 391
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K012405.
RHODIA DENTAL PUTTY IMPRESSION MATERIAL
K013129 · Rhodia, Inc. · Oct 2001
RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL
K013140 · Rhodia, Inc. · Oct 2001
NOVEL PRINT CYAN ALGINATES
K011785 · Manufacturera Dental Continental · Sep 2001
CAVEX STABISIL
K011452 · Cavex Holland BV · Jul 2001
CAVEX COLORCHANGE
K011419 · Cavex Holland BV · Jul 2001
SILICONE IMPRESSION MATERIAL
K011450 · Northeast Resins & Silicones, LLC · Jun 2001
K012405 · EXTRUDE MODIFIED
Download PDF FDA Summary Sybron Dental Special…