Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator

FDA 510(k) K242360 · Dent4you AG

Substantially Equivalent

510(k) numberK242360

Submission

Device name
Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator
Applicant
Dent4you AG
Heerbrugg, CH
Received
August 9, 2024
Decision date
November 15, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ELW – Material, Impression
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3660
Specialty
Dental

Other 510(k)s with product code ELW

510(k)DeviceApplicantDecision
K254112Dia-X Sil BiteELW · Traditional DiaDent Group International03/19/2026SE
K253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set -…ELW · Traditional Vigodent Indústria E Comercio Ltda10/31/2025SE
K250969Jet Bite; Jet Blue Bite Fast; Jet Blue Bite SuperfastELW · Abbreviated Dent4you AG06/27/2025SE
K241924Elastic Impression MaterialELW · Abbreviated Beijing Okvd Biological Technology , Ltd.12/27/2024SE
K233954Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-BluELW · Traditional B&E Korea Co., Ltd.02/13/2024SE
K223892DentMix VPS Impression MaterialELW · Traditional Innovative Product Brands, Inc.04/27/2023SE
K213175No Stress ImpressELW · Traditional No Stress Impress, LLC01/19/2023SE
K214086Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite…ELW · Traditional Genoss Co., Ltd.12/15/2022SE
K222741DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular…ELW · Traditional Hdi, Inc.11/07/2022SE
K213244Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil…ELW · Traditional Prevest Denpro Limited09/09/2022SE

More from Prevest Denpro Limited

510(k)DeviceDecision
K250969Jet Bite; Jet Blue Bite Fast; Jet Blue Bite SuperfastELW · Abbreviated 06/27/2025SE
K240801BioSonic US200 Ultrasonic Scaler (60034537)ELC · Traditional 07/01/2024SE
K223142Coltolux Comfort LED Curing LightEBZ · Traditional 12/22/2022SE

Questions and answers

When was Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator cleared by the FDA?

Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator (K242360) received a 510(k) decision of Substantially Equivalent on November 15, 2024, 98 days after the submission was received.

What is the product code of K242360?

The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.