Osstem Implant Co., Ltd. FDA Approvals

0 new drug approvals and 12 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Healing Abutment System510(k)Mar 4, 2026Dental	Dental	510(k)Substantially Equivalent (Traditional)	Mar 4, 2026
Bone Screw510(k)Aug 13, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Aug 13, 2025
Estar-ZE510(k)Nov 20, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Nov 20, 2024
T2 Plus510(k)Sep 6, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 6, 2024
TS Abutment System510(k)Feb 20, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Feb 20, 2024
SS Abutment System510(k)Dec 5, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 5, 2023
N1510(k)Nov 28, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Nov 28, 2023
Osstem Implant System510(k)Sep 23, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Sep 23, 2023
Osstem Abutment System510(k)Sep 8, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Sep 8, 2022
T2510(k)Sep 21, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 21, 2021
Estar-Z510(k)Jul 2, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 2, 2021
HySil Plus Impression Materials510(k)Mar 18, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Mar 18, 2021