ELW — Material, Impression Class II
FDA product code ELW covers "Material, Impression", a Class II medical device regulated under 21 CFR 872.3660. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254112 | diadent group international | Dia-X Sil Bite | March 19, 2026 |
| K253501 | vigodent indústria e comercio ltda | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular | October 31, 2025 |
| K250969 | dent4you | JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST | June 27, 2025 |
| K241924 | beijing okvd biological technology | Elastic Impression Material | December 27, 2024 |
| K242360 | dent4you | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex U | November 15, 2024 |
| K233954 | b and e korea co | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu | February 13, 2024 |
| K223892 | innovative product brands | DentMix VPS Impression Material | April 27, 2023 |
| K213175 | no stress impress | No Stress Impress | January 19, 2023 |
| K214086 | genoss co | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impres | December 15, 2022 |
| K222741 | hdi | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(R | November 7, 2022 |
| K213244 | prevest denpro limited | Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Ac | September 9, 2022 |
| K221668 | chemoment materials co | Dental Impression Material | August 8, 2022 |
| K213890 | imicryl dis malzemeleri san. ve tic. a.s | IMICRYL Impression Materials | February 11, 2022 |
| K220257 | 3m deutschland | Permadyne | February 1, 2022 |
| K220097 | coltène/whaledent | PRESIDENT The Original | January 13, 2022 |
| K211489 | nanchang dental bright technology co | Dental Impression Material | July 28, 2021 |
| K203824 | hygedent | VPS Impression Material | April 19, 2021 |
| K210041 | osstem implant co | HySil Plus Impression Materials | March 18, 2021 |
| K201483 | zhengzhou huaer electro optics technology co | Impression Material | October 8, 2020 |
| K201684 | shandong huge dental material corporation | A-Silicone for Bite Registration | September 24, 2020 |