Medical Device Manufacturer · KR , Busan

Osstem Implant Co., Ltd. - FDA 510(k) Cleared Devices

68 submissions · 68 cleared · Since 2006

Recent clearances: Healing Abutment System, Bone Screw, Estar-ZE

68
Total
68
Cleared
0
Denied

Osstem Implant Co., Ltd. has 68 FDA 510(k) cleared dental devices. Based in Busan, KR.

Latest FDA clearance: Mar 2026. Active since 2006.

Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Hiossen, Inc. as regulatory consultant.

FDA 510(k) Regulatory Record - Osstem Implant Co., Ltd.

68 devices
1-12 of 68

Looking for a specific device from Osstem Implant Co., Ltd.? Search by device name or K-number.

Search all Osstem Implant Co., Ltd. devices
Filters