ELW · Class II · 21 CFR 872.3660

FDA Product Code ELW: Material, Impression

Leading manufacturers include Zhermack S.P.A., Dentsply Intl. and Cavex Holland BV.

404
Total
404
Cleared
95d
Avg days
1976
Since
Growing category - 7 submissions in the last 2 years vs 4 in the prior period
Review times increasing: avg 142d recently vs 95d historically

FDA 510(k) Cleared Material, Impression Devices (Product Code ELW)

404 devices
1–24 of 404
Cleared Sep 16, 2026
Dia-X Sil Heavy Body
K254142
DiaDent Group International
Dental · 268d
Cleared Sep 16, 2026
Dia-X Sil Light Body
K254152
DiaDent Group International
Dental · 268d
Cleared Mar 19, 2026
Dia-X Sil Bite
K254112
DiaDent Group International
Dental · 90d
Cleared Oct 31, 2025
Hydro Print Premium Fast Set - 454g (1lb) (052037)
K253501
Vigodent Ind?stria E Comercio Ltda
Dental · 1d
Cleared Jun 27, 2025
JET BITE
K250969
Dent4you AG
Dental · 88d
Cleared Dec 27, 2024
Elastic Impression Material
K241924
Beijing Okvd Biological Technology , Ltd.
Dental · 179d
Cleared Nov 15, 2024
Speedex Light Body
K242360
Dent4you AG
Dental · 98d
Cleared Feb 13, 2024
Chemi-SiL (HB, MB, LB, LBS)
K233954
B&E Korea Co., Ltd.
Dental · 60d
Cleared Apr 27, 2023
DentMix VPS Impression Material
K223892
Innovative Product Brands, Inc.
Dental · 120d
Cleared Jan 19, 2023
No Stress Impress
K213175
No Stress Impress, LLC
Dental · 478d
Cleared Dec 15, 2022
Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty
K214086
Genoss Co., Ltd.
Dental · 353d
Cleared Nov 07, 2022
DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)
K222741
Hdi, Inc.
Dental · 59d
Cleared Sep 09, 2022
Accusil 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)
K213244
Prevest Denpro Limited
Dental · 344d
Cleared Aug 08, 2022
Dental Impression Material
K221668
Chemoment Materials Co.,Ltd
Dental · 61d
Cleared Feb 11, 2022
IMICRYL Impression Materials
K213890
Imicryl Dis Malzemeleri San. VE Tic. A.S.
Dental · 60d
Cleared Feb 01, 2022
Permadyne
K220257
3M Deutschland GmbH
Dental · 1d
Cleared Jan 13, 2022
PRESIDENT The Original
K220097
Colt?ne/Whaledent AG
Dental · 1d
Cleared Jul 28, 2021
Dental Impression Material
K211489
Nanchang Dental Bright Technology Co., Ltd.
Dental · 76d
Cleared Apr 19, 2021
VPS Impression Material
K203824
Hygedent, Inc.
Dental · 111d
Cleared Mar 18, 2021
HySil Plus Impression Materials
K210041
Osstem Implant Co., Ltd.
Dental · 70d
Cleared Oct 08, 2020
Impression Material
K201483
Zhengzhou Huaer Electro Optics Technology Co., Ltd.
Dental · 126d
Cleared Sep 24, 2020
A-Silicone for Bite Registration
K201684
Shandong Huge Dental Material Corporation
Dental · 94d
Cleared May 05, 2020
Lascod Impression Materials
K201184
Lascod Spa
Dental · 4d
Cleared Jan 30, 2020
HySil Super Fast Impression Materials
K192941
Osstem Implant Co., Ltd.
Dental · 104d

About Product Code ELW - Regulatory Context

510(k) Submission Activity

404 total 510(k) submissions under product code ELW since 1976, with 404 receiving FDA clearance (average review time: 95 days).

Submission volume has increased in recent years - 7 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - ELW Product Code

Recent submissions under ELW have taken an average of 142 days to reach a decision - up from 95 days historically. Manufacturers should account for longer review timelines in current project planning.

ELW devices are reviewed by the Dental panel. Browse all Dental devices →