# K242360: Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator

- Pathway: 510(k) (Traditional)
- Applicant: Dent4you AG
- Decided: Nov 15, 2024 after 98 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K943574 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220097: PRESIDENT The Original, Coltène/Whaledent AG (2022) Summary page 5.

## Indications for use
Speedex putty/putty soft - Primary impression in the putty-wash Impression technique - Pick-up impression in the simultaneous mixing technique - Impressions for study models, orthodontic models, keys and protective isolation of teeth during fitting of prostheses Speedex light body - Correction material for the correction impression technique - Syringe material for the two-phase impression technique - Impression material for relining Speedex medium - Complete and partial prosthetics, correction material for the correction impression technique - Monophase impression technique, simultaneous mixing technique - Liner impression material Speedex Universal Activator - Activator for Speedex putty; Speedex putty soft; Speedex light body; Speedex medium, for creating dental impressions

Source page: https://510kreport.com/device/K242360
Methodology: https://510kreport.com/methodology