ELW · Material, Impression
Dental · 21 CFR 872.3660 · Class 2
Overview
| Product Code | ELW |
|---|---|
| Device Name | Material, Impression |
| Regulation | 21 CFR 872.3660 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.
Classification Rationale
Class II (Special Controls).
Special Controls
*Classification.* Class II (Special Controls).
Recent Cleared Devices (20 of 402)
Showing 20 most recent of 402 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254112 | Dia-X Sil Bite | DiaDent Group International | Mar 19, 2026 | SESE |
| K253501 | Hydro 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 Ltda | Oct 31, 2025 | SESE |
| K250969 | JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST | Dent4you AG | Jun 27, 2025 | SESE |
| K241924 | Elastic Impression Material | Beijing Okvd Biological Technology , Ltd. | Dec 27, 2024 | SESE |
| K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator | Dent4you AG | Nov 15, 2024 | SESE |
| K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu | B&E Korea Co., Ltd. | Feb 13, 2024 | SESE |
| K223892 | DentMix VPS Impression Material | Innovative Product Brands, Inc. | Apr 27, 2023 | SESE |
| K213175 | No Stress Impress | No Stress Impress, LLC | Jan 19, 2023 | SESE |
| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty | Genoss Co., Ltd. | Dec 15, 2022 | SESE |
| K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) | Hdi, Inc. | Nov 7, 2022 | SESE |
| K213244 | 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) | Prevest Denpro Limited | Sep 9, 2022 | SESE |
| K221668 | Dental Impression Material | Chemoment Materials Co.,Ltd | Aug 8, 2022 | SESE |
| K213890 | IMICRYL Impression Materials | Imicryl Dis Malzemeleri San. VE Tic. A.S. | Feb 11, 2022 | SESE |
| K220257 | Permadyne | 3M Deutschland GmbH | Feb 1, 2022 | SESE |
| K220097 | PRESIDENT The Original | Coltène/Whaledent AG | Jan 13, 2022 | SESE |
| K211489 | Dental Impression Material | Nanchang Dental Bright Technology Co., Ltd. | Jul 28, 2021 | SESE |
| K203824 | VPS Impression Material | Hygedent, Inc. | Apr 19, 2021 | SESE |
| K210041 | HySil Plus Impression Materials | Osstem Implant Co., Ltd. | Mar 18, 2021 | SESE |
| K201483 | Impression Material | Zhengzhou Huaer Electro Optics Technology Co., Ltd. | Oct 8, 2020 | SESE |
| K201684 | A-Silicone for Bite Registration | Shandong Huge Dental Material Corporation | Sep 24, 2020 | SESE |
Top Applicants
- Zhermack S.P.A. — 19 clearances
- Dentsply Intl. — 18 clearances
- Cavex Holland BV — 16 clearances
- Heraeus Kulzer, Inc. — 15 clearances
- GC America, Inc. — 15 clearances
