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Sign in to claim this brandWhat OSSTEM IMPLANT Co., Ltd. makes
The company manufactures dental implant components, including permanent and temporary preformed suprastructures, reusable and single-use surgical tools like drill bits and screwdrivers, and custom-made ceramic crowns. Their portfolio also includes two-piece endosteal dental implants, implant analogs, and specialized tools such as paranasal sinus trephines and periosteal elevators.
These devices are classified under FDA regulations as Class I and Class II, with listings maintained in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable regulatory standards for dental and surgical instruments.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- osstem.com
- —
- —
- [email protected]
- Phone
- +1(821)012-3412
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 689051793
Catalogue (11489)
Page 14 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OsstemGuide Initial Drill | QGID20M | FDA UDI | Class I | Active |
| Bone Compaction Drill | BCD3511 | FDA UDI | Class I | Active |
| SS SA Fixture | SS3WB6013S20 | FDA UDI | Class II | Active |
| US SA Implant System | US3P5011S | FDA UDI | Class II | Active |
| SS SA Fixture | SS3R4010S28 | FDA UDI | Class II | Active |
| Ti Abutment Laboratory Waxing Screw | HGATSSW | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | 122NTPD7010 | FDA UDI | Class I | Active |
| ET Prosthetic System | HGTFA4555SNW | FDA UDI | Class II | Active |
| US/SS/GS System | SSA4820WH | FDA UDI | Class II | Active |
| Hiossen Prosthetic System | HGNCA451SHW | FDA UDI | Class II | Active |
| Prosthetic System | HGSAD356S | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAW715TH | FDA UDI | Class II | Active |
| US/SS/GS System | ASW200W | FDA UDI | Class II | Active |
| Estar-Z | ZHTA1020M | FDA UDI | Class II | Active |
| Rigid Driver | OTR60S | FDA UDI | Class I | Active |
| Rigid Impression Coping | HGRIC7005SS | FDA UDI | Class I | Active |
| ET/SS Implant System | ASS3R3508S28 | FDA UDI | Class II | Active |
| Hiossen Prosthetic System | ETHLAP5R | FDA UDI | Class II | Active |
| Solid Abutment Driver | SDSS | FDA UDI | Class I | Active |
| TS BA Fixture System | BTS3S5013B | FDA UDI | Class II | Active |
| Estar-Z | ZTA1018T | FDA UDI | Class II | Active |
| Estar-ZE | ZEHTA3512T | FDA UDI | Class II | Active |
| OneMS Path Drill | OMSD2007T | FDA UDI | Class I | Active |
| Hand Driver | AHD09SH | FDA UDI | Class I | Active |
| Three Cutter Twist Drill | H3D3006LC | FDA UDI | Class I | Active |
| Machine Screw Driver | HAMSD12E | FDA UDI | Class I | Active |
| Remover Body | HFRBW50L | FDA UDI | Class I | Active |
| Three Cutter Twist Drill | 3D3305T | FDA UDI | Class I | Active |
| Bone Compaction Drill | HBCDI13 | FDA UDI | Class I | Active |
| OSSTEM Implant System | BTS2S4510S | FDA UDI | Class II | Active |
| US/SS/GS System | GSGA4530BWH | FDA UDI | Class II | Active |
| OsstemGuide Twist Drill | QGTD4608 | FDA UDI | Class I | Active |
| Bone Compaction Drill | HBCD5011 | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS2S4008S | FDA UDI | Class II | Active |
| US/SS/GS System | GSAA4320BWH | FDA UDI | Class II | Active |
| 123 Twist Drill | 2D223013LC | FDA UDI | Class I | Active |
| HU/HS/HG Prosthetic System | HGTFA50105MHW | FDA UDI | Class II | Active |
| HA Mount | SSHRG | FDA UDI | Class I | Active |
| Expanding Osteotome | OST30EA | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS4S7007S | FDA UDI | Class II | Active |
| SMARTbuilder System | SMHA443 | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HUHLA4103R | FDA UDI | Class II | Active |
| US/SS/GS System | TAR100TH | FDA UDI | Class II | Active |
| SS SolidLab Analog | SSSA607 | FDA UDI | Class I | Active |
| Bone Graft Carrier | BGCR | FDA UDI | Class I | Active |
| Bone Profiler | HKSBP60 | FDA UDI | Class I | Active |
| Expansion Drill | OEXP223608 | FDA UDI | Class I | Active |
| Plastic Scaler Connector | HICSCK2 | FDA UDI | Class I | Active |
| Taper Drill | TPD3C3513 | FDA UDI | Class I | Active |
| OSSTEM Implant System | BTS3S4510S | FDA UDI | Class II | Active |
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