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ELW — Material, Impression Class II

FDA Device Classification

Classification Details

Product Code
ELW
Device Class
Class II
Regulation Number
872.3660
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253501vigodent indústria e comercio ltdaHydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular October 31, 2025
K250969dent4youJET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTJune 27, 2025
K241924beijing okvd biological technologyElastic Impression MaterialDecember 27, 2024
K242360dent4youSpeedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex UNovember 15, 2024
K233954b and e korea coChemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-BluFebruary 13, 2024
K223892innovative product brandsDentMix VPS Impression MaterialApril 27, 2023
K213175no stress impressNo Stress ImpressJanuary 19, 2023
K214086genoss coBright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright ImpresDecember 15, 2022
K222741hdiDENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(RNovember 7, 2022
K213244prevest denpro limitedAccusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, AcSeptember 9, 2022
K221668chemoment materials coDental Impression MaterialAugust 8, 2022
K213890imicryl dis malzemeleri san. ve tic. a.sIMICRYL Impression MaterialsFebruary 11, 2022
K2202573m deutschlandPermadyneFebruary 1, 2022
K220097coltène/whaledentPRESIDENT The OriginalJanuary 13, 2022
K211489nanchang dental bright technology coDental Impression MaterialJuly 28, 2021
K203824hygedentVPS Impression MaterialApril 19, 2021
K210041osstem implant coHySil Plus Impression MaterialsMarch 18, 2021
K201483zhengzhou huaer electro optics technology coImpression MaterialOctober 8, 2020
K201684shandong huge dental material corporationA-Silicone for Bite RegistrationSeptember 24, 2020
K201184lascodLascod Impression MaterialsMay 5, 2020