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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 1 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Osstem Abutment System | GSTA4672WH | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS3M3011S | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS3S4510S | FDA UDI | Class II | Active |
| Osstem Abutment System | TSPTA4070R | FDA UDI | Class II | Active |
| Periosteal Elevator | OM9 | FDA UDI | Class I | Active |
| SS SA Fixture | ASS2R4010S18 | FDA UDI | Class II | Active |
| ET/SS Implant System | SS3R4010S18 | FDA UDI | Class II | Active |
| Hiossen Prosthetic System | MGR100TH | FDA UDI | Class II | Active |
| 122 Taper Drill | 122TPD5507 | FDA UDI | Class I | Active |
| Multi Angled Abutment system | HGMAA317MHW | FDA UDI | Class II | Active |
| ET Prosthetic System | HGTFA7015SHW | FDA UDI | Class II | Active |
| OneGuide Taper Drill | HGTPD4507SWC | FDA UDI | Class I | Active |
| 485 Drill | O485D4505 | FDA UDI | Class I | Active |
| 485 Drill | H485D5004 | FDA UDI | Class I | Active |
| Estar-Z | ZHTC3014M | FDA UDI | Class II | Active |
| ET Rigid Impression Coping | ETRIC4005S | FDA UDI | Class I | Active |
| HS/HG Prosthetic System | HSCTA602WNT | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HUCMA60407WHPW | FDA UDI | Class II | Active |
| Hand Driver | AHD12SH | FDA UDI | Class I | Active |
| Countersink | D4UCS | FDA UDI | Class I | Active |
| Fixture Pick-up Impression Coping | HGFPI7015SN | FDA UDI | Class I | Active |
| OSSTEM Implant System | BTS4S5013S | FDA UDI | Class II | Active |
| Prosthetic System | HGCVA401MP | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HUUGA5512WHW | FDA UDI | Class II | Active |
| US/SS/GS System | SSA6020WH | FDA UDI | Class II | Active |
| US/SS/GS System | CAW634NWH | FDA UDI | Class II | Active |
| US/SS/GS System | COG600BTH | FDA UDI | Class II | Active |
| Prosthetic System | HGSAO353S | FDA UDI | Class II | Active |
| HS/HG Prosthetic System | HGCTC4010NT | FDA UDI | Class II | Active |
| GS System | GSHAS655 | FDA UDI | Class II | Active |
| OneCAS Twist Drill | HOCD2210 | FDA UDI | Class I | Active |
| Three Cutter Twist Drill | 3D2708LC | FDA UDI | Class I | Active |
| SS Digital Lab Analog | SSDLA600 | FDA UDI | Class I | Active |
| Taper Drill | TPD3C5511 | FDA UDI | Class I | Active |
| SS SA Fixture System | SS3W6013S20 | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS4S6008S | FDA UDI | Class II | Active |
| OneGuide Metal Sleeve | OGSCN50S | FDA UDI | Class I | Active |
| OSSTEM Implant System | BTS3S5006S | FDA UDI | Class II | Active |
| Estar-ZE | ZEHTB3018M | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAR514N | FDA UDI | Class II | Active |
| Solid Abutment Driver | SDRS | FDA UDI | Class I | Active |
| ET/SS Implant System | HGAGA604SBW | FDA UDI | Class II | Active |
| Taper Drill | TPD3C4008 | FDA UDI | Class I | Active |
| ET Prosthetic System | HGTFA4525SHW | FDA UDI | Class II | Active |
| SS SA Fixture System | ASS2R4015S28 | FDA UDI | Class II | Active |
| Bone Profiler | HABPW600C | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS4S6013S | FDA UDI | Class II | Active |
| Mount Driver | HASMDL | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS2M3510S | FDA UDI | Class II | Active |
| Osstem Abutment System | USPTA4060R | FDA UDI | Class II | Active |
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