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510(k) K242360

Device
Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator
Applicant
Dent4you AG
510(k) number
K242360
Product code
ELW
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-15
Date received
2024-08-09
Regulation
872.3660
Classification name
Material, Impression
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Oliver Ashe
Address
Bahnhofstrasse 2 Heerbrugg CH 9435 9435

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ELW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254112Dia-X Sil BiteDiaDent Group International2026-03-19
K253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);Vigodent Indústria E Comercio Ltda2025-10-31
K250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTDent4you AG2025-06-27
K241924Elastic Impression MaterialBeijing Okvd Biological Technology , Ltd.2024-12-27
K233954Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-BluB&E Korea Co., Ltd.2024-02-13
K223892DentMix VPS Impression MaterialInnovative Product Brands, Inc.2023-04-27
K213175No Stress ImpressNo Stress Impress, LLC2023-01-19
K214086Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-PuttyGenoss Co., Ltd.2022-12-15
K222741DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)Hdi, Inc.2022-11-07
K213244Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)Prevest Denpro Limited2022-09-09
K221668Dental Impression MaterialChemoment Materials Co.,Ltd2022-08-08
K213890IMICRYL Impression MaterialsImicryl Dis Malzemeleri San. VE Tic. A.S.2022-02-11
K220257Permadyne3M Deutschland GmbH2022-02-01
K220097PRESIDENT The OriginalColtène/Whaledent AG2022-01-13
K211489Dental Impression MaterialNanchang Dental Bright Technology Co., Ltd.2021-07-28