Product code EHD: 510(k) clearances and predicates
Product code EHD covers Hand-held Dental X-ray System (HyperLight-M). FDA lists 191 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
191 clearances on file under product code EHD. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 8 |
| 2023 | 8 |
| 2024 | 7 |
| 2025 | 1 |
| 2026 so far | 6 |
Recent clearances
Newest EHD clearances in the FDA index, with applicant and decision date:
- K260795, Hand-held Dental X-ray System (HyperLight-M), applicant Changzhou Sifary Medical Technology Co., Ltd., decided 2026-09-14. FDA record
- K260367, Portable Dental X-ray System Model PDX nova, applicant PDX Co., Ltd., decided 2026-05-27. FDA record
- K253864, NOMAD Pro 3, applicant Dental Imaging Technologies Corporation, decided 2026-03-20. FDA record
- K252110, Dental X-RAY Unit (AJX200), applicant Guangzhou Ajax Medical Equipment Co., Ltd., decided 2026-03-12. FDA record
- K254018, Portable Dental X-ray Device (GT-1), applicant Guilin Refine Medical Instrument Co., Ltd., decided 2026-02-19. FDA record
- K252909, Diagnostic X-Ray Equipment Model POCT22, applicant Ningbo Runyes Medical Instrument Co., Ltd., decided 2026-02-03. FDA record
- K251438, Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ), applicant Guilin Woodpecker Medical Instrument Co., Ltd., decided 2025-09-04. FDA record
- K242185, Rextar Pro, applicant Raypia Co., Ltd., decided 2024-12-04. 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 Portable Dental X-ray System Model PDX nova, NOMAD Pro 3. Watch new EHD 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 EHD?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent EHD clearances include Hand-held Dental X-ray System (HyperLight-M).
How many 510(k) clearances use product code EHD?
191 at the time this page was generated, from openFDA records.
How do I find a predicate device under EHD?
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 EHD clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.