K5
FDA 510(k) K233805 · Osstem Implant Co., Ltd. Chair Business
510(k) numberK233805
Submission
- Device name
- K5
- Applicant
- Osstem Implant Co., Ltd. Chair Business
Ansan-Si, KR - Received
- November 29, 2023
- Decision date
- September 3, 2024
- 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 |
| K251626 | Midmark Dental Delivery SystemEIA · Traditional | Midmark Corporation | 11/03/2025SE |
| 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 |
| 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 |
Questions and answers
When was K5 cleared by the FDA?
K5 (K233805) received a 510(k) decision of Substantially Equivalent on September 3, 2024, 279 days after the submission was received.
What is the product code of K233805?
The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.