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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 29 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HS/HG Prosthetic System | SSOCC600 | FDA UDI | Class II | Active |
| Estar-Z | ZP3C1022T | FDA UDI | Class II | Active |
| Estar-Z | ZP3A0025T | FDA UDI | Class II | Active |
| OsstemGuide Twist Drill | QGTD3608 | FDA UDI | Class I | Active |
| US/SS/GS System | CAR515TH | FDA UDI | Class II | Active |
| SB Anchor | SBA532520 | FDA UDI | Class II | Active |
| OneGuide US Fixture Driver | OGFDW57U | FDA UDI | Class I | Active |
| OSSTEM Implant System | BTS2M3510S | FDA UDI | Class II | Active |
| Trephine Drill | TD42S | FDA UDI | Class I | Active |
| Stopper | OABC2ST404L | FDA UDI | Class I | Active |
| US/SS/GS System | GSCPL600WH | FDA UDI | Class II | Active |
| Remover Body | FRBW57S | FDA UDI | Class I | Active |
| US/SS/GS System | TCAW5627TH | FDA UDI | Class II | Active |
| Bone Compaction Drill | BCDI13 | FDA UDI | Class I | Active |
| Rigid Burn-out Cylinder | ETRBC40S | FDA UDI | Class I | Active |
| Orthodontic Screw Hand Driver | OSTDA | FDA UDI | Class I | Active |
| Bone Mill Hammer | HABMH | FDA UDI | Class I | Active |
| Taper Drill | HTPD3C7010 | FDA UDI | Class I | Active |
| Three Cutter Twist Drill | 3D4111LC01 | FDA UDI | Class I | Active |
| Bone Compaction Drill | BCD5004 | FDA UDI | Class I | Active |
| ET Prosthetic System | HGRGA6024SP | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HGAGA45217SNW | FDA UDI | Class II | Active |
| US/SS/GS System | ERAR535C | FDA UDI | Class II | Active |
| US/SS/GS System | SSS485P | FDA UDI | Class II | Active |
| SS Solid Burn-out Cylinder | SSSP600S | FDA UDI | Class I | Active |
| HU/HS/HG Prosthetic System | HSOPC48RNT | FDA UDI | Class II | Active |
| US/SS/GS System | GSRA4620P | FDA UDI | Class II | Active |
| OneGuide Taper Drill | OGTPD4510W | FDA UDI | Class I | Active |
| OneGuide Taper Drill | OGTPD5507W | FDA UDI | Class I | Active |
| US/SS/GS System | GSTA5410WH | FDA UDI | Class II | Active |
| SS Implant Transfer Impression Coping | SSCTIL600 | FDA UDI | Class I | Active |
| US SA Implant System | US2P5018S | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSTA6650NWH | FDA UDI | Class II | Active |
| US SA Implant System | US2W5015S | FDA UDI | Class II | Active |
| Positioning Guide | HAPG202 | FDA UDI | Class I | Active |
| OneCAS Drill | HOCD4110WC | FDA UDI | Class I | Active |
| Bone Compaction Drill | BCD3504 | FDA UDI | Class I | Active |
| Ts Fixture System | BTS2S5015S | FDA UDI | Class II | Active |
| Osstem Implant System | TSSHA404RTH | FDA UDI | Class II | Active |
| Estar-ZE | ZEHTB3016M | FDA UDI | Class II | Active |
| OneGuide Taper Drill | OGTPD4506 | FDA UDI | Class I | Active |
| OneGuide Taper Drill | OGTPD5508SWC | FDA UDI | Class I | Active |
| US SA Implant System | US2R4508S | FDA UDI | Class II | Active |
| Reamer Tip | GSRFRT600 | FDA UDI | Class I | Active |
| OSSTEM Implant System | TSHA407R | FDA UDI | Class II | Active |
| Three Cutter Twist Drill | 3D3311LC01 | FDA UDI | Class I | Active |
| Remover Screw | FRSMI325F | FDA UDI | Class I | Active |
| Et/Ss Implant System | SS3W4508S20 | FDA UDI | Class II | Active |
| GS System | GS25FA7030 | FDA UDI | Class II | Active |
| MS SA Implant System | MSN3011S25 | FDA UDI | Class II | Active |
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