Cleared Traditional

K062400 - IMPRESSIX

K062400 is an FDA 510(k) clearance for IMPRESSIX, 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 92-day FDA review.

K062400 · Cavex Holland BV · Dental device
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Nov 2006
Decision
92d
Days
Class 2
Risk

K062400 is an FDA 510(k) clearance for the IMPRESSIX, COLORCHANGE ALGINATE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Cavex Holland BV (Haarlem, NL). The FDA issued a Cleared decision on November 16, 2006 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Cavex Holland BV devices

FDA 510(k) Submission Details - K062400

510(k) Number K062400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2006
Decision Date November 16, 2006
Days to Decision 92 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
35d faster than avg
Panel avg: 127d · This submission: 92d
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 K062400.
CEREC OPTI SPRAY
K080882 · Sirona Dental Systems GmbH · Apr 2008
PECD-01 AND PECD QUICK-01
K080514 · 3M Espe AG Dental Products · Mar 2008
EMULATE ADVANCED
K072245 · Cavex Holland BV · Nov 2007
VIRTUAL
K060891 · Ivoclar Vivadent, Inc. · Jul 2006
SIMULATE, COLOR CHANGE ALGINATE
K061267 · Cavex Holland BV · Jul 2006
PRE-IMPRESSION CONDITIONING SOLUTION
K061427 · Dentsply Intl. · Jun 2006