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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 12 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| US/SS/GS System | GSFA5530NWH | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS4S6013S | FDA UDI | Class II | Active |
| US/SS/GS System | GSTA6620WH | FDA UDI | Class II | Active |
| US/SS/GS System | GSRAS4610P | FDA UDI | Class II | Active |
| Osstem Abutment System | GSMABSM | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HUSFA60204WT | FDA UDI | Class II | Active |
| Osstem Abutment System | USPTA5010W | FDA UDI | Class II | Active |
| US Polishing Protector | UPCW100 | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS4S5011S | FDA UDI | Class II | Active |
| SS Digital Lab Analog | SSDLA480 | FDA UDI | Class I | Active |
| HS/HG Prosthetic System | HGRTC5005S | FDA UDI | Class II | Active |
| Bone Compaction Drill | BCD5013 | FDA UDI | Class I | Active |
| 122 Taper Drill | H122TPD3511 | FDA UDI | Class I | Active |
| OSSTEM Implant System - Abutment | GSRAS4420P | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSTA5750NWH | FDA UDI | Class II | Active |
| Taper Drill | HTPD3C5510 | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS3S5011S | FDA UDI | Class II | Active |
| TS BA Fixture System | BTS3M3508B | FDA UDI | Class II | Active |
| Trephine Drill | HTD47 | FDA UDI | Class I | Active |
| Abutment Positioning Driver | HAPDL | FDA UDI | Class I | Active |
| SS SA Fixture System | SS2R4007S28 | FDA UDI | Class II | Active |
| Estar-Z | ZP9D4010T | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSTA5410WH | FDA UDI | Class II | Active |
| Estar-Z | ZSTB2022T | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS2S4513S | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSTA5440WH | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS4S4508S | FDA UDI | Class II | Active |
| Guide | OGNR04L | FDA UDI | Class I | Active |
| US SA Implant System | US2W5018S | FDA UDI | Class II | Active |
| SS Excellent Solid Burn-out Cylinder | SSEP600B | FDA UDI | Class I | Active |
| OSSTEM Implant System | BTS4S4010S | FDA UDI | Class II | Active |
| Estar-ZE | ZEHTC1022M | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS2M3513S | FDA UDI | Class II | Active |
| Estar-Z | ZTD2018T | FDA UDI | Class II | Active |
| Fixture Driver | USRFDL | FDA UDI | Class I | Active |
| TS Implant Transfer Impression Coping | GSTIS4511N | FDA UDI | Class I | Active |
| NoMount Driver | HUSNMD35MS | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTA3522T | FDA UDI | Class II | Active |
| Estar-Z | ZP9C1014T | FDA UDI | Class II | Active |
| OssBuilder System | SMHI420USR | FDA UDI | Class II | Active |
| OneGuide Taper Drill | OGTPD5511WC | FDA UDI | Class I | Active |
| Us System | AIHR602 | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | AIHR407 | FDA UDI | Class II | Active |
| Three Cutter Twist Drill | 3D3013FNLC | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTA4022M | FDA UDI | Class II | Active |
| Guide Screw | GSBGS | FDA UDI | Class I | Active |
| Fixture Pick-up Impression Coping | HGFPI4515SN | FDA UDI | Class I | Active |
| SET Drill | SET274110 | FDA UDI | Class I | Active |
| Abutment Removal Tip | OARTREL | FDA UDI | Class I | Active |
| Initial Drill | OGID2206IWC | FDA UDI | Class I | Active |
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