FDA product code EIA: Unit, Operative Dental
EIA is the FDA product code for unit, operative dental. It is a Class I device, regulated under 21 CFR 872.6640 and reviewed by the Dental panel. FDA has cleared 285 510(k) submissions under EIA, 17 in the last five years, from 194 different applicants. The average 510(k) review took 141 days (median 89); 282 days on average over the last three years. FDA has posted 4 recalls for EIA devices.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Operative Dental |
| Device class | Class I |
| Regulation | 21 CFR 872.6640 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EIA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 569 |
| 2018 | 2 | 288 |
| 2019 | 2 | 263 |
| 2020 | 1 | 666 |
| 2022 | 3 | 222 |
| 2023 | 3 | 707 |
| 2024 | 3 | 177 |
| 2025 | 7 | 224 |
| 2026 | 1 | 444 |
Compare with all 510(k) review times · Search every EIA clearance
Top EIA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| A-Dec, Inc. | 25 | 2022-03-02 |
| Aseptico, Inc. | 5 | 2011-04-11 |
| Sirona Dental Systems GmbH | 4 | 2015-07-24 |
| Trophy Radiologie | 4 | 2004-02-02 |
| Air Techniques, Inc. | 4 | 1999-03-22 |
189 more applicants have EIA clearances. See the full list in Caduvo.
Most recent EIA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251544 | Lakong Medical Devices Co., Ltd. | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | 2026-08-07 | 444 |
| K251626 | Midmark Corporation | Midmark Dental Delivery System | 2025-11-03 | 159 |
| K251491 | Osstem Implant Company., Ltd. Chair Business | K5 Cart, K5 Mount, K5 Swing | 2025-07-17 | 64 |
| K243130 | Guangdong Yadeng Medical Apparatus Co., Ltd., | Integral Dental Unit | 2025-06-27 | 270 |
| K242611 | Mipont Medical Equipment Co., Ltd. | Integral Dental Units | 2025-05-27 | 266 |
Recalls for EIA devices
4 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-06-24.
Frequently asked questions
What is FDA product code EIA?
EIA is the FDA product code for unit, operative dental. It is a Class I device, regulated under 21 CFR 872.6640 and reviewed by the Dental panel.
What device class is EIA?
Class I, regulation 21 CFR 872.6640. Typical premarket route: 510(k).
How long does a 510(k) take for product code EIA?
Across 285 cleared submissions the average was 141 days from receipt to decision (median 89).
Which companies have the most EIA clearances?
A-Dec, Inc. (25); Aseptico, Inc. (5); Sirona Dental Systems GmbH (4); Trophy Radiologie (4); Air Techniques, Inc. (4).
Have EIA devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2016-06-24.
Next steps
- Run an FDA pathway report with predicate devices for product code EIA
- Run a recall and safety report across every EIA manufacturer
- Watch product code EIA 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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