FDA product code EIH: Powder, Porcelain
EIH is the FDA product code for powder, porcelain. It is a Class II device, regulated under 21 CFR 872.6660 and reviewed by the Dental panel. FDA has cleared 487 510(k) submissions under EIH, 84 in the last five years, from 226 different applicants. The average 510(k) review took 110 days (median 87); 90 days on average over the last three years. FDA has posted 35 recalls for EIH devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Powder, Porcelain |
| Device class | Class II |
| Regulation | 21 CFR 872.6660 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EIH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 16 | 178 |
| 2018 | 10 | 233 |
| 2019 | 16 | 145 |
| 2020 | 13 | 199 |
| 2021 | 17 | 158 |
| 2022 | 16 | 125 |
| 2023 | 15 | 128 |
| 2024 | 28 | 117 |
| 2025 | 13 | 76 |
| 2026 | 12 | 76 |
Compare with all 510(k) review times · Search every EIH clearance
Top EIH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dentsply Intl. | 23 | 2013-02-22 |
| Prismatik Dentalcraft, Inc. | 21 | 2026-07-30 |
| Vident | 16 | 2006-04-27 |
| Wieland Dental + Technik GmbH & Co. KG | 14 | 2015-12-16 |
| Noritake Co., Inc. | 14 | 2011-08-12 |
221 more applicants have EIH clearances. See the full list in Caduvo.
Most recent EIH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262074 | Mediclus Co., Ltd. | Any-Zircos | 2026-08-21 | 60 |
| K262239 | Prismatik Dentalcraft, Inc. | Obsidian® Press Over Zirconia | 2026-07-30 | 29 |
| K261046 | Hunan Qinghao Puzhong Technology Co., Ltd. | Dental Zirconia Blank & Coloring Liquid | 2026-07-17 | 108 |
| K262195 | Zima International Inc., dba Dandy | Dandy Ceramic Stain and Glaze | 2026-06-30 | 1 |
| K260918 | Amann Girrbach AG | Zolid Lunaris | 2026-06-29 | 102 |
Recalls for EIH devices
35 product recalls in 7 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2025-12-11.
| Year | Recalls |
|---|---|
| 2020 | 5 |
| 2024 | 6 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code EIH?
EIH is the FDA product code for powder, porcelain. It is a Class II device, regulated under 21 CFR 872.6660 and reviewed by the Dental panel.
What device class is EIH?
Class II, regulation 21 CFR 872.6660. Typical premarket route: 510(k).
How long does a 510(k) take for product code EIH?
Across 487 cleared submissions the average was 110 days from receipt to decision (median 87).
Which companies have the most EIH clearances?
Dentsply Intl. (23); Prismatik Dentalcraft, Inc. (21); Vident (16); Wieland Dental + Technik GmbH & Co. KG (14); Noritake Co., Inc. (14).
Have EIH devices been recalled?
Yes: 35 product recalls across 7 recall events; the most recent began 2025-12-11.
Next steps
- Run an FDA pathway report with predicate devices for product code EIH
- Run a recall and safety report across every EIH manufacturer
- Watch product code EIH 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.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times