Cleared Traditional

K011419 - CAVEX COLORCHANGE

K011419 is an FDA 510(k) clearance for CAVEX COLORCHANGE, manufactured by Cavex Holland BV. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K011419 · Cavex Holland BV · Dental device
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Jul 2001
Decision
68d
Days
Class 2
Risk

K011419 is an FDA 510(k) clearance for the CAVEX COLORCHANGE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Cavex Holland BV (Rw Haarlem (Holland), NL). The FDA issued a Cleared decision on July 16, 2001 after a review of 68 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 Cavex Holland BV devices

FDA 510(k) Submission Details - K011419

510(k) Number K011419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2001
Decision Date July 16, 2001
Days to Decision 68 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 127d · This submission: 68d
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 195
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K011419.
LUXABITE
K013236 · Dmg USA, Inc. · Oct 2001
EXTRUDE MODIFIED
K012405 · Sybron Dental Specialties, Inc. · Sep 2001
CAVEX STABISIL
K011452 · Cavex Holland BV · Jul 2001
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