Cleared Traditional

K011452 - CAVEX STABISIL

K011452 is an FDA 510(k) clearance for CAVEX STABISIL, 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 69-day FDA review.

K011452 · Cavex Holland BV · Dental device
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Jul 2001
Decision
69d
Days
Class 2
Risk

K011452 is an FDA 510(k) clearance for the CAVEX STABISIL. 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 19, 2001 after a review of 69 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 - K011452

510(k) Number K011452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2001
Decision Date July 19, 2001
Days to Decision 69 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: 128d · This submission: 69d
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 341
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K011452.
RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL
K013140 · Rhodia, Inc. · Oct 2001
NOVEL PRINT CYAN ALGINATES
K011785 · Manufacturera Dental Continental · Sep 2001
EXTRUDE MODIFIED
K012405 · Sybron Dental Specialties, Inc. · Sep 2001
CAVEX COLORCHANGE
K011419 · Cavex Holland BV · Jul 2001
SILICONE IMPRESSION MATERIAL
K011450 · Northeast Resins & Silicones, LLC · Jun 2001
TAKE ONE BITE MODIFIED
K010994 · Kerr Corp. · Apr 2001