Company ยท US
Osstem Implant Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2026. Name variants (Inc, Corp, punctuation) are merged.
68510(k) clearances (1 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 27 |
| NHA | Abutment, Implant, Dental, Endosseous | 18 |
| OAS | X-Ray, Tomography, Computed, Dental | 6 |
| ELW | Material, Impression | 5 |
| DZL | Screw, Fixation, Intraosseous | 3 |
| EHD | Unit, X-Ray, Extraoral With Timer | 3 |
| JEY | Plate, Bone | 3 |
| EIA | Unit, Operative Dental | 2 |
| EIH | Powder, Porcelain | 2 |
| OAT | Implant, Endosseous, Orthodontic | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 4, 2026 | K251434 | Healing Abutment System Osstem Implant Co., Ltd., KR | NHA |
| Aug 13, 2025 | K251569 | Bone Screw Osstem Implant Co., Ltd., KR | DZL |
| Nov 20, 2024 | K242521 | Estar-ZE Osstem Implant Co., Ltd., KR | EIH |
| Sep 6, 2024 | K233806 | T2 Plus Osstem Implant Co., Ltd., KR | OAS |
| Feb 20, 2024 | K233194 | TS Abutment System Osstem Implant Co., Ltd., KR | NHA |
| Dec 5, 2023 | K232220 | SS Abutment System Osstem Implant Co., Ltd., KR | NHA |
| Nov 28, 2023 | K232012 | N1 Osstem Implant Co., Ltd., KR | EHD |
| Sep 23, 2023 | K222778 | Osstem Implant System Osstem Implant Co., Ltd., KR | DZE |
| Sep 8, 2022 | K221684 | Osstem Abutment System Osstem Implant Co., Ltd., KR | NHA |
| Sep 21, 2021 | K212303 | T2 Osstem Implant Co., Ltd., KR | OAS |
| Jul 2, 2021 | K210097 | Estar-Z Osstem Implant Co., Ltd., KR | EIH |
| Mar 18, 2021 | K210041 | HySil Plus Impression Materials Osstem Implant Co., Ltd., KR | ELW |
| Jan 30, 2020 | K192941 | HySil Super Fast Impression Materials Osstem Implant Co., Ltd., KR | ELW |
| Sep 4, 2019 | K183347 | K3 Osstem Implant Co., Ltd., KR | EIA |
| Aug 30, 2019 | K183475 | T1-CS, T1-C Osstem Implant Co., Ltd., KR | OAS |
| Aug 9, 2019 | K182881 | Bone Screw, Bone Tack Osstem Implant Co., Ltd., KR | DZL |
| Jul 12, 2019 | K182091 | Osstem Abutment System Osstem Implant Co., Ltd., KR | NHA |
| May 7, 2019 | K181854 | OssBuilder System Osstem Implant Co., Ltd., KR | DZL |
| Sep 13, 2018 | K181236 | HySil Impression Materials Osstem Implant Co., Ltd., KR | ELW |
| Mar 26, 2018 | K172354 | OssBuilder System Osstem Implant Co., Ltd., KR | JEY |
| Jun 7, 2017 | K170736 | HySil Impression Materials Osstem Implant Co., Ltd., KR | ELW |
| May 22, 2017 | K161689 | OSSTEM Implant System - Abutment Osstem Implant Co., Ltd., KR | NHA |
| May 15, 2017 | K163557 | SS SA Fixture Osstem Implant Co., Ltd., KR | DZE |
| Apr 25, 2017 | K160670 | ET US SS Prosthetic system Osstem Implant Co., Ltd., KR | NHA |
| Apr 21, 2017 | K163088 | TSIII BA Fixture Osstem Implant Co., Ltd., KR | DZE |
| Apr 20, 2017 | K152830 | K3 Osstem Implant Co., Ltd., KR | EIA |
| Feb 2, 2017 | K161103 | US SA Implant System Osstem Implant Co., Ltd., KR | DZE |
| Dec 21, 2016 | K161197 | Orthodontic Screw Osstem Implant Co., Ltd., KR | OAT |
| Dec 5, 2016 | K153015 | Transfer & Angled Abutment Osstem Implant Co., Ltd., KR | NHA |
| Oct 28, 2016 | K160519 | Link Abutment for CEREC Osstem Implant Co., Ltd., KR | NHA |
| Oct 17, 2016 | K161604 | OSSTEM Implant System Osstem Implant Co., Ltd., KR | DZE |
| Sep 21, 2015 | K151262 | Hyflex Heavy, Hyflex Mono, Hyflex Light Osstem Implant Co., Ltd., KR | ELW |
| Aug 26, 2014 | K141497 | PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) Osstem Implant Co., Ltd. | EHD |
| Aug 21, 2014 | K140600 | SB ANCHOR Osstem Implant Co., Ltd. | NHA |
| Aug 20, 2014 | K140507 | HIOSSEN PROSTHETIC SYSTEM Osstem Implant Co., Ltd. | NHA |
| Jan 10, 2014 | K130662 | ET PROSTHETIC SYSTEM Osstem Implant Co., Ltd. | NHA |
| Sep 18, 2013 | K130840 | SMARTBUILDER SYSTEM (SB1) Osstem Implant Co., Ltd. | JEY |
| May 16, 2013 | K122124 | PORTABLE X-RAY SYSTEM Osstem Implant Co., Ltd. | EHD |
| Apr 26, 2013 | K123755 | MULTI ANGLED ABUTMENT Osstem Implant Co., Ltd. | NHA |
| Jan 7, 2013 | K121585 | TS IMPLANT SYSTEM Osstem Implant Co., Ltd. | DZE |
| Dec 11, 2012 | K121843 | NP-CAST ABUTMENT SYSTEM Osstem Implant Co., Ltd. | NHA |
| Nov 29, 2012 | K121995 | TS FIXTURE SYSTEM Osstem Implant Co., Ltd. | DZE |
| Nov 16, 2012 | K122171 | MS SA IMPLANT SYSTEM Osstem Implant Co., Ltd. | DZE |
| Oct 3, 2012 | K120951 | SMARTBUILDER SYSTEM Osstem Implant Co., Ltd. | JEY |
| Aug 10, 2012 | K120847 | ET/SS IMPLANT SYSTEM Osstem Implant Co., Ltd. | DZE |
| Oct 3, 2011 | K110308 | PROSTHETIC SYSTEM Osstem Implant Co., Ltd. | NHA |
| Mar 25, 2011 | K103105 | ORTHODONTIC SCREW Osstem Implant Co., Ltd. | OAT |
| Aug 17, 2010 | K100245 | HS/HG PROSTHETIC SYSTEM Osstem Implant Co., Ltd. | NHA |
| Mar 3, 2010 | K091208 | GS III SYSTEM Osstem Implant Co., Ltd. | DZE |
| Feb 18, 2010 | K091678 | HG II SHORT FIXTURE SYSTEM Osstem Implant Co., Ltd. | DZE |
Newest 50 of 68.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2025 | OSSTEM Implant Co., Ltd. Osstem Dental X-Ray System T2Plus. Product Model Numbers
T2-C-P and T2-CS-P. Open, Classified |
OAS | K233806 |
| Nov 5, 2025 | OSSTEM Implant Co., Ltd. Osstem Dental X-Ray System T2. Product Model Numbers
T2-C and T2-CS. Open, Classified |
OAS | K212303 |
| Nov 5, 2025 | OSSTEM Implant Co., Ltd. Osstem Dental X-Ray System T1. Product Model Numbers
T1-C and T1-CS. Open, Classified |
OAS | K183475 |