Product code ELW
- Device name
- Material, Impression
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3660
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254142 | Dia-X Sil Heavy Body | DiaDent Group International | 2026-09-16 |
| K254152 | Dia-X Sil Light Body | DiaDent Group International | 2026-09-16 |
| K254112 | Dia-X Sil Bite | DiaDent Group International | 2026-03-19 |
| 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 (1l... | Vigodent Indústria E Comercio Ltda | 2025-10-31 |
| K250969 | JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST | Dent4you AG | 2025-06-27 |
| K241924 | Elastic Impression Material | Beijing Okvd Biological Technology , Ltd. | 2024-12-27 |
| K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator | Dent4you AG | 2024-11-15 |
| K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu | B&E Korea Co., Ltd. | 2024-02-13 |
| K223892 | DentMix VPS Impression Material | Innovative Product Brands, Inc. | 2023-04-27 |
| K213175 | No Stress Impress | No Stress Impress, LLC | 2023-01-19 |
| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty | Genoss Co., Ltd. | 2022-12-15 |
| K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) | Hdi, Inc. | 2022-11-07 |
| 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 | 2022-09-09 |
| K221668 | Dental Impression Material | Chemoment Materials Co.,Ltd | 2022-08-08 |
| K213890 | IMICRYL Impression Materials | Imicryl Dis Malzemeleri San. VE Tic. A.S. | 2022-02-11 |
| K220257 | Permadyne | 3M Deutschland GmbH | 2022-02-01 |
| K220097 | PRESIDENT The Original | Coltène/Whaledent AG | 2022-01-13 |
| K211489 | Dental Impression Material | Nanchang Dental Bright Technology Co., Ltd. | 2021-07-28 |
| K203824 | VPS Impression Material | Hygedent, Inc. | 2021-04-19 |
| K210041 | HySil Plus Impression Materials | Osstem Implant Co., Ltd. | 2021-03-18 |
| K201483 | Impression Material | Zhengzhou Huaer Electro Optics Technology Co., Ltd. | 2020-10-08 |
| K201684 | A-Silicone for Bite Registration | Shandong Huge Dental Material Corporation | 2020-09-24 |
| K201184 | Lascod Impression Materials | Lascod Spa | 2020-05-05 |
| K192941 | HySil Super Fast Impression Materials | Osstem Implant Co., Ltd. | 2020-01-30 |
| K190571 | StoneBite and StoneBite scan | Dreve Dentamid GmbH | 2019-11-07 |
| K191034 | VPS Impression Material | Hygedent, Inc. | 2019-09-04 |
| K181604 | Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite | Hrs Co., Ltd. | 2018-11-28 |
| K181236 | HySil Impression Materials | Osstem Implant Co., Ltd. | 2018-09-13 |
| K181011 | AIM2 | GC America, Inc. | 2018-07-12 |
| K180565 | PEAK NS033CF, PEAK NS017CF | Neosil Co., Ltd. | 2018-06-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08056640081826 | Ormalab 75 | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640083202 | Alginkid | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640083196 | Alginmax | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640083141 | Alginmax | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640083134 | Alginmax | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640083080 | Alginmax | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640083042 | Alginmajor | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640082991 | Alginmajor | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640082601 | Ormalab 85 | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640082038 | Ormalab 95 | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640082014 | Ormalab 95 | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640082007 | Ormalab 95 | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640081994 | Ormalab 95 | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640081925 | Ormalab 85 | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640081833 | Ormalab 75 | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640080997 | Ormadent Putty | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640081819 | Ormalab 75 | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640081802 | Ormalab 75 | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640081741 | Ormaplus lab | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640081734 | Ormaplus lab | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640081673 | Ormaplus lab | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640081666 | Ormaplus lab | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640081642 | Ormaplus lab | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640081611 | Ormaplus lab | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640081604 | Ormaplus lab | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640081598 | Ormaplus lab | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640081185 | Ormamax | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640081161 | Ormamax | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640081109 | Ormactivator | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |
| 08056640081093 | Ormactivator | MAJOR PRODOTTI DENTARI SPA | 2026-10-20 |