Product code ELW: 510(k) clearances and predicates
Product code ELW covers Dia-X Sil Heavy Body. FDA lists 404 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
404 clearances on file under product code ELW. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 7 |
| 2023 | 2 |
| 2024 | 3 |
| 2025 | 2 |
| 2026 so far | 3 |
Recent clearances
Newest ELW clearances in the FDA index, with applicant and decision date:
- K254142, Dia-X Sil Heavy Body, applicant DiaDent Group International, decided 2026-09-16. FDA record
- K254152, Dia-X Sil Light Body, applicant DiaDent Group International, decided 2026-09-16. FDA record
- K254112, Dia-X Sil Bite, applicant DiaDent Group International, decided 2026-03-19. FDA record
- 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);, applicant Vigodent Indústria E Comercio Ltda, decided 2025-10-31. FDA record
- K250969, JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST, applicant Dent4you AG, decided 2025-06-27. FDA record
- K241924, Elastic Impression Material, applicant Beijing Okvd Biological Technology , Ltd., decided 2024-12-27. FDA record
- K242360, Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator, applicant Dent4you AG, decided 2024-11-15. FDA record
- K233954, Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu, applicant B&E Korea Co., Ltd., decided 2024-02-13. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Dia-X Sil Light Body, Dia-X Sil Bite. Watch new ELW clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code ELW?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent ELW clearances include Dia-X Sil Heavy Body.
How many 510(k) clearances use product code ELW?
404 at the time this page was generated, from openFDA records.
How do I find a predicate device under ELW?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new ELW clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.