Midmark Dental Delivery System
FDA 510(k) K251626 · Midmark Corporation
510(k) numberK251626
Submission
- Device name
- Midmark Dental Delivery System
- Applicant
- Midmark Corporation
Versailles, OH, US - Received
- May 28, 2025
- Decision date
- November 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EIA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)EIA · Traditional | Lakong Medical Devices Co., Ltd. | 08/07/2026SE |
| K251491 | K5 Cart, K5 Mount, K5 SwingEIA · Special | Osstem Implant Company., Ltd. Chair Business | 07/17/2025SE |
| K243130 | Integral Dental UnitEIA · Traditional | Guangdong Yadeng Medical Apparatus Co., Ltd., | 06/27/2025SE |
| K242611 | Integral Dental UnitsEIA · Traditional | Mipont Medical Equipment Co., Ltd. | 05/27/2025SE |
| K250473 | Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusEIA · Traditional | Dci International, LLC | 02/19/2025SE |
| K242404 | BDC Dental UnitEIA · Traditional | Bdc Dental Corporation , Ltd. | 02/07/2025SE |
| K231297 | Firstar Dental UnitEIA · Traditional | Firstar Dental Company | 01/27/2025SE |
| K233805 | K5EIA · Traditional | Osstem Implant Co., Ltd. Chair Business | 09/03/2024SE |
| K240754 | N2EIA · Special | Megagen Implant Co., Ltd. | 03/21/2024SE |
| K231845 | Dental unit Model: MareEIA · Traditional | Foshan Safety Medical Equipment Co., Ltd. | 02/28/2024SE |
More from Foshan Safety Medical Equipment Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)MWI · Traditional | 06/12/2026SE |
| K233026 | Midmark Smart M9® Sterilizer, Midmark Smart M11® SterilizerFLE · Traditional | 04/04/2024SE |
| K201667 | Midmark Extraoral Imaging System (EOIS)OAS · Traditional | 08/06/2020SE |
| K163337 | Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D…FLE · Traditional | 08/31/2017SE |
| K161909 | IQvitals ZoneMWI · Traditional | 11/17/2016SE |
| K122643 | Vantage Model V5000, V5100, V5000C, V5100CMUH · Traditional | 01/07/2013SE |
| K120239 | ElevanceEIA · Special | 08/24/2012SE |
| K112380 | ClearvisionMUH · Traditional | 11/22/2011SE |
| K091866 | Progeny Vantage Panoramic X-Ray SystemMUH · Traditional | 07/20/2009SE |
| K090670 | Midmark M3 Ultrafast Automatic SterilizerFLE · Traditional | 07/07/2009SE |
Questions and answers
When was Midmark Dental Delivery System cleared by the FDA?
Midmark Dental Delivery System (K251626) received a 510(k) decision of Substantially Equivalent on November 3, 2025, 159 days after the submission was received.
What is the product code of K251626?
The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.