ClearanceBrief
Panels › Dental › Product code ELW · Class 2

Material, Impression

Regulation 872.3660

3510(k)s in 12 months (404 all time)
0recalls in 12 months (14 all time)
13recalls that name a 510(k)
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Top companies in ELW

Company510(k)sRecalls
Heraeus Kulzer, Inc.214
Zhermack S.P.A.190
Dentsply Intl.180
Cavex Holland BV160
GC America, Inc.150
Harry J. Bosworth Co.101
Sybron Dental Specialties101
Zhermack Dental Production110
Crown Delta Corp.100
Espe Dental AG100
Decided510(k)Device and applicantCode
Sep 16, 2026K254152Dia-X Sil Light Body
DiaDent Group International, KR
ELW
Sep 16, 2026K254142Dia-X Sil Heavy Body
DiaDent Group International, KR
ELW
Mar 19, 2026K254112Dia-X Sil Bite
DiaDent Group International, KR
ELW
Oct 31, 2025K253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print
Vigodent Indústria E Comercio Ltda, BR
ELW
Jun 27, 2025K250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST
Dent4you AG, CH
ELW
Dec 27, 2024K241924Elastic Impression Material
Beijing Okvd Biological Technology , Ltd., CN
ELW
Nov 15, 2024K242360Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator
Dent4you AG, CH
ELW
Feb 13, 2024K233954Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
B&E Korea Co., Ltd., KR
ELW
Apr 27, 2023K223892DentMix VPS Impression Material
Innovative Product Brands, Inc.
ELW
Jan 19, 2023K213175No Stress Impress
No Stress Impress, LLC
ELW
Dec 15, 2022K214086Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty
Genoss Co., Ltd., KR
ELW
Nov 7, 2022K222741DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)
Hdi, Inc., KR
ELW
Sep 9, 2022K213244Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, A
Prevest Denpro Limited, IN
ELW
Aug 8, 2022K221668Dental Impression Material
Chemoment Materials Co.,Ltd, CN
ELW
Feb 11, 2022K213890IMICRYL Impression Materials
Imicryl Dis Malzemeleri San. VE Tic. A.S., TR
ELW
Feb 1, 2022K220257Permadyne
3M Deutschland GmbH, DE
ELW
Jan 13, 2022K220097PRESIDENT The Original
Coltène/Whaledent AG, CH
ELW
Jul 28, 2021K211489Dental Impression Material
Nanchang Dental Bright Technology Co., Ltd., CN
ELW
Apr 19, 2021K203824VPS Impression Material
Hygedent, Inc., CN
ELW
Mar 18, 2021K210041HySil Plus Impression Materials
Osstem Implant Co., Ltd., KR
ELW
Oct 8, 2020K201483Impression Material
Zhengzhou Huaer Electro Optics Technology Co., Ltd., CN
ELW
Sep 24, 2020K201684A-Silicone for Bite Registration
Shandong Huge Dental Material Corporation, CN
ELW
May 5, 2020K201184Lascod Impression Materials
Lascod Spa, IT
ELW
Jan 30, 2020K192941HySil Super Fast Impression Materials
Osstem Implant Co., Ltd., KR
ELW
Nov 7, 2019K190571StoneBite and StoneBite scan
Dreve Dentamid GmbH, DE
ELW
Sep 4, 2019K191034VPS Impression Material
Hygedent, Inc., CN
ELW
Nov 28, 2018K181604Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite
Hrs Co., Ltd., KR
ELW
Sep 13, 2018K181236HySil Impression Materials
Osstem Implant Co., Ltd., KR
ELW
Jul 12, 2018K181011AIM2
GC America, Inc.
ELW
Jun 13, 2018K180565PEAK NS033CF, PEAK NS017CF
Neosil Co., Ltd., KR
ELW
Apr 13, 2018K171562Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
Dreve Dentamid GmbH, DE
ELW
Oct 31, 2017K173318Rapid HB, Rapid LB, Rapid MB
3M Deutschland GmbH, DE
ELW
Jul 26, 2017K170812HygePLUS Alginate Impression Material
Hygedent, Inc., CN
ELW
Jun 7, 2017K170736HySil Impression Materials
Osstem Implant Co., Ltd., KR
ELW
Nov 3, 2016K152615Vonflex S
Vericom Co., Ltd., KR
ELW
Sep 30, 2016K161774i-Sil
Spident Co., Ltd., KR
ELW
Aug 5, 2016K160097Image Fast Set, Image Regular Set
Sybron Dental Specialties
ELW
Jun 30, 2016K160441Identic and KromaFaze Alginate Dental Impression Materials
Kerr Corporation
ELW
May 27, 2016K152826NoCord
Centrix, Inc.
ELW
Mar 8, 2016K152766CharmFlex
Dentkist, Inc., KR
ELW
Mar 4, 2016K152861Aquasil Ultra + Smart Wetting Impression Material
Dentply International, Inc.
ELW
Nov 30, 2015K152518Vonflex S Putty
Vericom Co., Ltd., KR
ELW
Nov 23, 2015K152349Star+ VPS Scannable Impression Material
Danville Materials, LLC
ELW
Oct 28, 2015K151535Cavex Cream Alginate
Cavex Holland BV, NL
ELW
Oct 22, 2015K152180PEAK
Neosil Co., Ltd., KR
ELW
Sep 21, 2015K151262Hyflex Heavy, Hyflex Mono, Hyflex Light
Osstem Implant Co., Ltd., KR
ELW
Jul 28, 2015K151150Elements
Pac-Dent International, Inc.
ELW
Apr 3, 2015K143575Accu-Dent XD Tray, Accu-Dent XD Syringe
Ivoclar Vivadent, Inc.
ELW
Feb 23, 2015K143382DentiAnn Smart Sil
Seilglobal Co., Ltd., KR
ELW
Dec 4, 2014K141092MARK3
Cavex Holland BV, NL
ELW

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