ELW
- Product code
- ELW
- Device name
- Material, Impression
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.3660
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 402
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254112 | 2026-03-19 | DiaDent Group International | Dia-X Sil Bite | |
| K253501 | 2025-10-31 | Vigodent Indústria E Comercio Ltda | Hydro Print Premium Fast Set - 454g (1lb) (052037); | |
| K250969 | 2025-06-27 | Dent4you AG | JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAS | |
| K241924 | 2024-12-27 | Beijing Okvd Biological Technology , L | Elastic Impression Material | |
| K242360 | 2024-11-15 | Dent4you AG | Speedex Light Body; Speedex Medium; Speedex Putty; S | |
| K233954 | 2024-02-13 | B&E Korea Co., Ltd. | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu |
Official FDA classification page: ELW
Classification and pathway per current FDA publications. Data from openFDA (CC0).