FDA product code ELW: Material, Impression
ELW is the FDA product code for material, impression. It is a Class II device, regulated under 21 CFR 872.3660 and reviewed by the Dental panel. FDA has cleared 404 510(k) submissions under ELW, 17 in the last five years, from 162 different applicants. The average 510(k) review took 95 days (median 70); 122 days on average over the last three years. FDA has posted 14 recalls for ELW devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Material, Impression |
| Device class | Class II |
| Regulation | 21 CFR 872.3660 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for ELW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 77 |
| 2018 | 5 | 158 |
| 2019 | 2 | 192 |
| 2020 | 4 | 82 |
| 2021 | 3 | 86 |
| 2022 | 7 | 126 |
| 2023 | 2 | 299 |
| 2024 | 3 | 112 |
| 2025 | 2 | 44 |
| 2026 | 3 | 209 |
Compare with all 510(k) review times · Search every ELW clearance
Top ELW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zhermack S.P.A. | 19 | 2009-03-26 |
| Dentsply Intl. | 18 | 2006-06-26 |
| Cavex Holland BV | 16 | 2015-10-28 |
| GC America, Inc. | 15 | 2018-07-12 |
| Heraeus Kulzer, Inc. | 15 | 2009-07-31 |
157 more applicants have ELW clearances. See the full list in Caduvo.
Most recent ELW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254152 | DiaDent Group International | Dia-X Sil Light Body | 2026-09-16 | 268 |
| K254142 | DiaDent Group International | Dia-X Sil Heavy Body | 2026-09-16 | 268 |
| K254112 | DiaDent Group International | Dia-X Sil Bite | 2026-03-19 | 90 |
| K253501 | Vigodent Indústria E Comercio Ltda | 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); | 2025-10-31 | 1 |
| K250969 | Dent4you AG | JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST | 2025-06-27 | 88 |
Recalls for ELW devices
14 product recalls in 8 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-03-18.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code ELW?
ELW is the FDA product code for material, impression. It is a Class II device, regulated under 21 CFR 872.3660 and reviewed by the Dental panel.
What device class is ELW?
Class II, regulation 21 CFR 872.3660. Typical premarket route: 510(k).
How long does a 510(k) take for product code ELW?
Across 404 cleared submissions the average was 95 days from receipt to decision (median 70).
Which companies have the most ELW clearances?
Zhermack S.P.A. (19); Dentsply Intl. (18); Cavex Holland BV (16); GC America, Inc. (15); Heraeus Kulzer, Inc. (15).
Have ELW devices been recalled?
Yes: 14 product recalls across 8 recall events; the most recent began 2022-03-18.
Next steps
- Run an FDA pathway report with predicate devices for product code ELW
- Run a recall and safety report across every ELW manufacturer
- Watch product code ELW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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