EIA
- Product code
- EIA
- Device name
- Unit, Operative Dental
- Device class
- Class 1
- 21 CFR
- 21 CFR 872.6640
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 11
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 285 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (11)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251544 | 2026-08-07 | Lakong Medical Devices Co., Ltd. | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | — |
| K251626 | 2025-11-03 | Midmark Corporation | Midmark Dental Delivery System | |
| K251491 | 2025-07-17 | Osstem Implant Company., Ltd. Chair Bu… | K5 Cart, K5 Mount, K5 Swing | FDA |
| K243130 | 2025-06-27 | Guangdong Yadeng Medical Apparatus Co.… | Integral Dental Unit | FDA |
| K242611 | 2025-05-27 | Mipont Medical Equipment Co., Ltd. | Integral Dental Units | |
| K250473 | 2025-02-19 | Dci International, LLC | Dental Delivery System Series 5 and Dental Delivery … | — |
| K242404 | 2025-02-07 | Bdc Dental Corporation , Ltd. | BDC Dental Unit | |
| K231297 | 2025-01-27 | Firstar Dental Company | Firstar Dental Unit | |
| K233805 | 2024-09-03 | Osstem Implant Co., Ltd. Chair Busines… | K5 | |
| K240754 | 2024-03-21 | Megagen Implant Co., Ltd. | N2 | |
| K231845 | 2024-02-28 | Foshan Safety Medical Equipment Co., L… | Dental unit Model: Mare |
Official FDA classification page: EIA
Classification and pathway per current FDA publications. Data from openFDA (CC0).