Cleared Traditional

K012405 - EXTRUDE MODIFIED

K012405 is the FDA 510(k) clearance for EXTRUDE MODIFIED by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (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)
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.

View all Sybron Dental Specialties, Inc. devices

Submission Details

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
91d faster than avg
Panel avg: 127d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 124
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K012405.
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K021416 · Dentsply Intl. · May 2002
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K021413 · Dentsply Intl. · May 2002
AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL
K021410 · Dentsply Intl. · May 2002
TAKE 1
K003808 · Sybron Dental Specialties, Inc. · Mar 2001
PERMLASTIC 3
K003650 · Sybron Dental Specialties, Inc. · Feb 2001
FLEXTIME MAGNUM 360
K003930 · Heraeus Kulzer, Inc. · Feb 2001