K5 Cart, K5 Mount, K5 Swing

FDA 510(k) K251491 · Osstem Implant Company., Ltd. Chair Business

Substantially Equivalent

510(k) numberK251491

Submission

Device name
K5 Cart, K5 Mount, K5 Swing
Applicant
Osstem Implant Company., Ltd. Chair Business
Ansan-Si, KR
Received
May 14, 2025
Decision date
July 17, 2025
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EIA – Unit, Operative Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.6640
Specialty
Dental

Other 510(k)s with product code EIA

510(k)DeviceApplicantDecision
K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)EIA · Traditional Lakong Medical Devices Co., Ltd.08/07/2026SE
K251626Midmark Dental Delivery SystemEIA · Traditional Midmark Corporation11/03/2025SE
K243130Integral Dental UnitEIA · Traditional Guangdong Yadeng Medical Apparatus Co., Ltd.,06/27/2025SE
K242611Integral Dental UnitsEIA · Traditional Mipont Medical Equipment Co., Ltd.05/27/2025SE
K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusEIA · Traditional Dci International, LLC02/19/2025SE
K242404BDC Dental UnitEIA · Traditional Bdc Dental Corporation , Ltd.02/07/2025SE
K231297Firstar Dental UnitEIA · Traditional Firstar Dental Company01/27/2025SE
K233805K5EIA · Traditional Osstem Implant Co., Ltd. Chair Business09/03/2024SE
K240754N2EIA · Special Megagen Implant Co., Ltd.03/21/2024SE
K231845Dental unit Model: MareEIA · Traditional Foshan Safety Medical Equipment Co., Ltd.02/28/2024SE

Questions and answers

When was K5 Cart, K5 Mount, K5 Swing cleared by the FDA?

K5 Cart, K5 Mount, K5 Swing (K251491) received a 510(k) decision of Substantially Equivalent on July 17, 2025, 64 days after the submission was received.

What is the product code of K251491?

The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.