Cleared Traditional

K242360 - Speedex Light Body

Also marketed or referenced as:
Speedex Medium Speedex Putty Speedex Putty Soft Speedex Universal Activator

K242360 is an FDA 510(k) clearance for Speedex Light Body, manufactured by Dent4you AG. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K242360 · Dent4you AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
98d
Days
Class 2
Risk

K242360 is an FDA 510(k) clearance for the Speedex Light Body. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Dent4you AG (Heerbrugg, CH). The FDA issued a Cleared decision on November 15, 2024 after a review of 98 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 Dent4you AG devices

FDA 510(k) Submission Details - K242360

510(k) Number K242360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2024
Decision Date November 15, 2024
Days to Decision 98 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
29d faster than avg
Panel avg: 127d · This submission: 98d
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 K242360.
Hydro Print Premium Fast Set - 454g (1lb) (052037)
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K250969 · Dent4you AG · Jun 2025
Elastic Impression Material
K241924 · Beijing Okvd Biological Technology , Ltd. · Dec 2024
Chemi-SiL (HB, MB, LB, LBS)
K233954 · B&E Korea Co., Ltd. · Feb 2024
DentMix VPS Impression Material
K223892 · Innovative Product Brands, Inc. · Apr 2023
No Stress Impress
K213175 · No Stress Impress, LLC · Jan 2023