Cleared Traditional

K062400 - IMPRESSIX, COLORCHANGE ALGINATE (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K062400 · Cavex Holland BV · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 401
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K062400.
Dia-X Sil Bite
K254112 · DiaDent Group International · Mar 2026
Hydro Print Premium Fast Set - 454g (1lb) (052037)
K253501 · Vigodent Ind?stria E Comercio Ltda · Oct 2025
JET BITE
K250969 · Dent4you AG · Jun 2025
Elastic Impression Material
K241924 · Beijing Okvd Biological Technology , Ltd. · Dec 2024
Speedex Light Body
K242360 · Dent4you AG · Nov 2024
Chemi-SiL (HB, MB, LB, LBS)
K233954 · B&E Korea Co., Ltd. · Feb 2024