Product code EIH: 510(k) clearances and predicates
Product code EIH covers Any-Zircos. FDA lists 487 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
487 clearances on file under product code EIH. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 16 |
| 2023 | 15 |
| 2024 | 28 |
| 2025 | 13 |
| 2026 so far | 12 |
Recent clearances
Newest EIH clearances in the FDA index, with applicant and decision date:
- K262074, Any-Zircos, applicant Mediclus Co., Ltd., decided 2026-08-21. FDA record
- K262239, Obsidian® Press Over Zirconia, applicant Prismatik Dentalcraft, Inc., decided 2026-07-30. FDA record
- K261046, Dental Zirconia Blank & Coloring Liquid, applicant Hunan Qinghao Puzhong Technology Co., Ltd., decided 2026-07-17. FDA record
- K262195, Dandy Ceramic Stain and Glaze, applicant Zima International Inc., dba Dandy, decided 2026-06-30. FDA record
- K260918, Zolid Lunaris, applicant Amann Girrbach AG, decided 2026-06-29. FDA record
- K260859, Rosetta SM, Rosetta SP, applicant Hass Corp., decided 2026-06-11. FDA record
- K253191, DCMhotbond zircon, applicant Dental Creativ Management GmbH, decided 2026-05-21. FDA record
- K260067, Eternal Art Porcelain Powders, applicant Shandong Huge Dental Material Corporation, decided 2026-04-09. 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 Obsidian® Press Over Zirconia, Dental Zirconia Blank & Coloring Liquid. Watch new EIH 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 EIH?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent EIH clearances include Any-Zircos.
How many 510(k) clearances use product code EIH?
487 at the time this page was generated, from openFDA records.
How do I find a predicate device under EIH?
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 EIH clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.