Osstem Implant Co., Ltd.
Osstem Implant Co., Ltd. holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2026, with 3 FDA device recalls on record.
Top product codes for Osstem Implant Co., Ltd.
FDA recalls by Osstem Implant Co., Ltd.
- Z-0314-2026 — Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
- Z-0313-2026 — Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
- Z-0315-2026 — Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Osstem Implant Co., Ltd.
- K251434 — Healing Abutment System
- K251569 — Bone Screw
- K242521 — Estar-ZE
- K233806 — T2 Plus
- K233194 — TS Abutment System
- K232220 — SS Abutment System
- K232012 — N1
- K222778 — Osstem Implant System
- K221684 — Osstem Abutment System
- K212303 — T2
- K210097 — Estar-Z
- K210041 — HySil Plus Impression Materials
- K192941 — HySil Super Fast Impression Materials
- K183347 — K3
- K183475 — T1-CS, T1-C
- K182881 — Bone Screw, Bone Tack
- K182091 — Osstem Abutment System
- K181854 — OssBuilder System
- K181236 — HySil Impression Materials
- K172354 — OssBuilder System
- K170736 — HySil Impression Materials
- K161689 — OSSTEM Implant System - Abutment
- K163557 — SS SA Fixture
- K160670 — ET US SS Prosthetic system
- K163088 — TSIII BA Fixture
- K152830 — K3
- K161103 — US SA Implant System
- K161197 — Orthodontic Screw
- K153015 — Transfer & Angled Abutment
- K160519 — Link Abutment for CEREC
- K161604 — OSSTEM Implant System
- K151262 — Hyflex Heavy, Hyflex Mono, Hyflex Light
- K141497 — PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)
- K140600 — SB ANCHOR
- K140507 — HIOSSEN PROSTHETIC SYSTEM
- K130662 — ET PROSTHETIC SYSTEM
- K130840 — SMARTBUILDER SYSTEM (SB1)
- K122124 — PORTABLE X-RAY SYSTEM
- K123755 — MULTI ANGLED ABUTMENT
- K121585 — TS IMPLANT SYSTEM
- K121843 — NP-CAST ABUTMENT SYSTEM
- K121995 — TS FIXTURE SYSTEM
- K122171 — MS SA IMPLANT SYSTEM
- K120951 — SMARTBUILDER SYSTEM
- K120847 — ET/SS IMPLANT SYSTEM
- K110308 — PROSTHETIC SYSTEM
- K103105 — ORTHODONTIC SCREW
- K100245 — HS/HG PROSTHETIC SYSTEM
- K091208 — GS III SYSTEM
- K091678 — HG II SHORT FIXTURE SYSTEM
- K083633 — HS II SHORT FIXTURE SYSTEM
- K083067 — MS SYSTEM
- K081786 — ZIOCERA & CONVERTIBLE SYSTEM
- K082213 — GS III FIXTURE SYSTEM
- K080594 — MS SYSTEM (NARROW RIDGE)
- K081575 — HU/HS/HG PROSTHETIC SYSTEM
- K080744 — HG II FIXTURE SYSTEM
- K081078 — NT/IT SYSTEM
- K073465 — US/GS ULTRA WIDE SYSTEM
- K073247 — US/SS/GS SYSTEM
- K080387 — HU II / HS II FIXTURE SYSTEM
- K072959 — MS SYSTEM (DENTURE)
- K072871 — MS SYSTEM (PROVISIONAL)
- K072896 — GS FIXTURE SYSTEM
- K063861 — GS SYSTEM
- K062030 — US SYSTEM
- K062051 — SS SYSTEM
- K062156 — SUPER ORTHODONTIC SCREW
Data sourced from openFDA. This site is unofficial and independent of the FDA.