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Sign in to claim this brandOSSTEM IMPLANT CO., LTD.
South Korea·KR-MF-000020006
Last updated September 17, 2026
Information
- Country
- South Korea
- Address
- 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do,15079, Republic of Korea, Siheung-si, South Korea
- Website
- osstem.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Heekwon Son
- EUDAMED SRN
- KR-MF-000020006
- FDA FEI Number
- 3031886796
- DUNS Number
- —
Catalogue (500)
Page 3 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hg Ii Short Fixture System | K091678 | FDA 510(k) | Class II | Active |
| TSIII BA Fixture | K163088 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Gs Iii System | K091208 | FDA 510(k) | Class II | Active |
| SS SA Fixture | K163557 | FDA 510(k) | Class II | Active |
| Portable X-Ray System | K122124 | FDA 510(k) | Class II | Active |
| Hs Ii Short Fixture System | K083633 | FDA 510(k) | Class II | Active |
| Smartbuilder System | K120951 | FDA 510(k) | Class II | Active |
| Sb Anchor | K140600 | FDA 510(k) | Class II | Active |
| Ziocera & Convertible System | K081786 | FDA 510(k) | Class II | Active |
| Us/Gs Ultra Wide System | K073465 | FDA 510(k) | Class II | Active |
| OssBuilder System | K172354 | FDA 510(k) | Class II | Active |
| Ms System (narrow Ridge) | K080594 | FDA 510(k) | Class II | Active |
| SS Abutment System | K232220 | FDA 510(k) | Class II | Active |
| Super Orthodontic Screw | K062156 | FDA 510(k) | Class II | Active |
| Gs Fixture System | K072896 | FDA 510(k) | Class II | Active |
| HySil Plus Impression Materials | K210041 | FDA 510(k) | Class II | Active |
| Estar-ZE | K242521 | FDA 510(k) | Class II | Active |
| OssBuilder System | K181854 | FDA 510(k) | Class II | Active |
| Ss System | K062051 | FDA 510(k) | Class II | Active |
| HySil Super Fast Impression Materials | K192941 | FDA 510(k) | Class II | Active |
| Hu/Hs/Hg Prosthetic System | K081575 | FDA 510(k) | Class II | Active |
| Hg Ii Fixture System | K080744 | FDA 510(k) | Class II | Active |
| Hyflex Heavy, Hyflex Mono, Hyflex Light | K151262 | FDA 510(k) | Class II | Active |
| US SA Implant System | K161103 | EUDAMEDFDA 510(k) | Class II | Active |
| Ts Implant System | K121585 | FDA 510(k) | Class II | Active |
| Gs Iii Fixture System | K082213 | FDA 510(k) | Class II | Active |
| Ms System (denture) | K072959 | FDA 510(k) | Class II | Active |
| Estar-Z | K210097 | FDA 510(k) | Class II | Active |
| Us System | K062030 | FDA 510(k)FDA UDI | Class II | Active |
| HySil Impression Materials | K181236 | FDA 510(k) | Class II | Active |
| OneMS Drill | OMD1513 | EUDAMEDFDA UDI | Class IIa | Active |
| Orthodontic Screw Driver Tip | OSSDT | EUDAMEDFDA UDI | Class I | Active |
| Countersink | D4UCS | EUDAMEDFDA UDI | Class IIa | Active |
| O-ring Set | OAON01S | EUDAMEDFDA UDI | Class IIb | Active |
| Twist Drill | 2D2215FNLC | EUDAMEDFDA UDI | Class IIa | Active |
| Bone Profiler | ABPM400C | EUDAMEDFDA UDI | Class IIa | Active |
| Twist Drill | OSMSD23L | EUDAMEDFDA UDI | Class IIa | Active |
| SS Solid Impression Coping | SSIC604 | EUDAMEDFDA UDI | Class I | Active |
| TS Scan body | TSSBSTH | EUDAMEDFDA UDI | Class I | Active |
| Twist Drill | O485D2208 | EUDAMEDFDA UDI | Class IIa | Active |
| Bone Carrier | OCBCS30 | EUDAMEDFDA UDI | Class I | Active |
| 122 Taper Drill | 122TPD4013 | EUDAMEDFDA UDI | Class IIa | Active |
| OneGuide Taper Drill | OGTPD4011 | EUDAMEDFDA UDI | Class IIa | Active |
| Twist Drill | 2D2207LC01 | EUDAMEDFDA UDI | Class IIa | Active |
| ESR Full KIT | HESRFK | EUDAMED | Class IIa | Active |
| Guide | OGSB02S | EUDAMEDFDA UDI | Class I | Active |
| MS Implant Provisional | MST18134 | EUDAMEDFDA UDI | Class IIb | Active |
| TS Fixture Transfer Impression Coping | GSTIS5011N | EUDAMEDFDA UDI | Class I | Active |
| 122 Taper Drill | 122TPD7013 | EUDAMEDFDA UDI | Class IIa | Active |
| Tissue punch | OSTP33 | EUDAMEDFDA UDI | Class IIa | Active |
Related Companies
Authorised Representatives
- Obelis s.a. BE
Importers
Not available yet.
Notified Bodies
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Authorities
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- OSSTEM IMPLANT Co., Ltd. US