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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 15 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Estar-ZE | ZEHTD3018T | FDA UDI | Class II | Active |
| US/SS/GS System | CAR625N | FDA UDI | Class II | Active |
| SS Solid Impression Coping | SSIC484 | FDA UDI | Class I | Active |
| Mount Driver | ASMDS | FDA UDI | Class I | Active |
| Orthodontic Screw Machine Driver | OSMDB | FDA UDI | Class I | Active |
| KS Remover Screw | KSFRSW50 | FDA UDI | Class I | Active |
| 122 Taper Drill | H122TPD6006 | FDA UDI | Class I | Active |
| Osstem Implant System | TSSHA605RB | FDA UDI | Class II | Active |
| SS SA Fixture System | SS3R3510S28 | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS3S6010S | FDA UDI | Class II | Active |
| SS SA Fixture | SS2W5007S20 | FDA UDI | Class II | Active |
| Osstem Abutment System | TSMC500NTH | FDA UDI | Class II | Active |
| 122 Taper Drill | H122TPD3507 | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS3S4007S | FDA UDI | Class II | Active |
| Ridge Split Chisel | HRSS15 | FDA UDI | Class I | Active |
| US Angled Abutment Selector | USAS004TH | FDA UDI | Class I | Active |
| OSSTEM Implant System - Abutment | GSFA6030NWH | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS4S7011S | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS3M3515S | FDA UDI | Class II | Active |
| Estar-Z | ZHTB1012T | FDA UDI | Class II | Active |
| OssBuilder System | OBAC430020 | FDA UDI | Class II | Active |
| TSIII BA Fixture | BTS3S5013B | FDA UDI | Class II | Active |
| OsstemGuide Drill Guide | QGDG20W | FDA UDI | Class I | Active |
| Us System | AIHR504 | FDA UDI | Class II | Active |
| SS SA Fixture | SS3W5013S20 | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS3S5015S | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS2S5008S | FDA UDI | Class II | Active |
| Perforation Drill | HRPED2007 | FDA UDI | Class I | Active |
| OSSTEM Implant System | TSHA505R | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSTA4631NWH | FDA UDI | Class II | Active |
| Guide | OGUML | FDA UDI | Class I | Active |
| Estar-Z | ZP9C3012T | FDA UDI | Class II | Active |
| Excellent Solid Abutment Driver | ESD60S | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | MER100 | FDA UDI | Class II | Active |
| Three Cutter Twist Drill | 3D4315FNLC01 | FDA UDI | Class I | Active |
| OneGuide Path Drill | OGSD3007 | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | CAW725TH | FDA UDI | Class II | Active |
| Us System | AIHR503 | FDA UDI | Class II | Active |
| US NoMount Driver | USNMD41RL | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTC4014M | FDA UDI | Class II | Active |
| Osstem Implant System | TSSHA457RTH | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS4S4013S | FDA UDI | Class II | Active |
| Reverse Driver | ORVDML | FDA UDI | Class I | Active |
| Abutment Holder | HOABH | FDA UDI | Class I | Active |
| Surgical Tap | UTSGTP60L | FDA UDI | Class I | Active |
| Ts Snapon Mount | GSSMS | FDA UDI | Class I | Active |
| Prosthetic System | GSCAM12N | FDA UDI | Class II | Active |
| Orthodontic Screw System | OSSH1608 | FDA UDI | Class II | Active |
| SS SA Fixture System | SS3W5006S20 | FDA UDI | Class II | Active |
| Taper Drill | TPD3C5513 | FDA UDI | Class I | Active |
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