EIA — Unit, Operative Dental Class I
FDA Device Classification
Classification Details
- Product Code
- EIA
- Device Class
- Class I
- Regulation Number
- 872.6640
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251626 | midmark corporation | Midmark Dental Delivery System | November 3, 2025 |
| K251491 | osstem implant company., ltd. chair business | K5 Cart, K5 Mount, K5 Swing | July 17, 2025 |
| K243130 | guangdong yadeng medical apparatus co., ltd | Integral Dental Unit | June 27, 2025 |
| K242611 | mipont medical equipment co | Integral Dental Units | May 27, 2025 |
| K250473 | dci international | Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus | February 19, 2025 |
| K242404 | bdc dental corporation | BDC Dental Unit | February 7, 2025 |
| K231297 | firstar dental | Firstar Dental Unit | January 27, 2025 |
| K233805 | osstem implant co., ltd. chair business | K5 | September 3, 2024 |
| K240754 | megagen implant co | N2 | March 21, 2024 |
| K231845 | foshan safety medical equipment co | Dental unit Model: Mare | February 28, 2024 |
| K202963 | mgnewton | ELEC Master, ELEC Master Dual | May 5, 2023 |
| K211556 | megagen implant co | N2 | April 5, 2023 |
| K213749 | shinhung company | G7, Dental Operative Unit and Accessories | April 3, 2023 |
| K220873 | lares research | Perceptive electric dental motor and control unit | December 15, 2022 |
| K213742 | olsen indústria e comércio | Infinity Pro, Logic, Quality, Sprint | October 19, 2022 |
| K213932 | a-dec | A-dec 300, A-dec 500 | March 2, 2022 |
| K180935 | olsen industria e comercio | Infinity / Infinity Cross Flex Dental Systems | February 5, 2020 |
| K183347 | osstem implant co | K3 | September 4, 2019 |
| K183121 | aiobio co | Qraypen | July 18, 2019 |
| K173608 | forest dental products | Forest Dental Unit | August 17, 2018 |