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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 39 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Parallel Pin | HAPP600 | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | AIHR505 | FDA UDI | Class II | Active |
| Taper Drill | HTPD3C4015 | FDA UDI | Class I | Active |
| Taper Drill | TPTD3C4507T | FDA UDI | Class I | Active |
| ET Prosthetic System | HGRGA4035SP | FDA UDI | Class II | Active |
| Positioning Guide | APG203 | FDA UDI | Class I | Active |
| US/SS/GS System | CAR615TH | FDA UDI | Class II | Active |
| TSIII BA Fixture | TS3M3508B | FDA UDI | Class II | Active |
| US NoMount Driver | USNMD51WL | FDA UDI | Class I | Active |
| US/GS Ultra Wide System | GSTA7620NWH | FDA UDI | Class II | Active |
| HS/HG Prosthetic System | HSSAO484R | FDA UDI | Class II | Active |
| Reverse Driver | HRVDML | FDA UDI | Class I | Active |
| OSSTEM Implant System - Abutment | GSZAS4550WH | FDA UDI | Class II | Active |
| US SA Implant System | AUS3W5011S | FDA UDI | Class II | Active |
| Estar-ZE | ZEHTC3016M | FDA UDI | Class II | Active |
| OneGuide Twist Drill | OGTD2211T | FDA UDI | Class I | Active |
| Sa Mount | USUR13 | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTC2014M | FDA UDI | Class II | Active |
| ET/SS Implant System | GSCA6010P | FDA UDI | Class II | Active |
| ET Prosthetic System | HGTFA5017SHW | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS4S4515S | FDA UDI | Class II | Active |
| Sa Mount | USUR13 | FDA UDI | Class I | Active |
| Us/Ss/Gs System | AUS3W515AR | FDA UDI | Class II | Active |
| HySil Impression Materials | ESS50LB | FDA UDI | Class II | Active |
| ET/SS Implant System | HGCMA23MNW | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS2S5018S | FDA UDI | Class II | Active |
| OneCAS Drill | OCD3310WC | FDA UDI | Class I | Active |
| US/SS/GS System | COG480STH | FDA UDI | Class II | Active |
| SS SA Fixture | ASS2W5008S20 | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS2S5013S | FDA UDI | Class II | Active |
| SS SA Fixture | ASS2R4508S28 | FDA UDI | Class II | Active |
| 123 Twist Drill | 3D556508LC | FDA UDI | Class I | Active |
| Mallet | HOSTMP | FDA UDI | Class I | Active |
| US/SS/GS System | TPSW200TH | FDA UDI | Class II | Active |
| Taper Drill | TPD3C4015 | FDA UDI | Class I | Active |
| Osstem Abutment System | GSTA4752WH | FDA UDI | Class II | Active |
| US/SS/GS System | GCW100TH | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSRA4630P | FDA UDI | Class II | Active |
| 122 Taper Drill | 122TPD4504 | FDA UDI | Class I | Active |
| Taper Drill | HTPD3C3513 | FDA UDI | Class I | Active |
| Bone Compaction Drill | HBCD3507 | FDA UDI | Class I | Active |
| Estar-Z | ZP3C4012T | FDA UDI | Class II | Active |
| Long Shank Countersink | ACD375C | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTD3025T | FDA UDI | Class II | Active |
| Osteotome Stopper Set | HST20SH | FDA UDI | Class I | Active |
| 123 Twist Drill | H2D223015LC | FDA UDI | Class I | Active |
| Orthodontic Screw Removal Tool | HSRT20H | FDA UDI | Class I | Active |
| Direct Drill | 3D5213FNLC | FDA UDI | Class I | Active |
| Osstem Abutment System | GSAA4540MAWH | FDA UDI | Class II | Active |
| Estar-Z | ZHTC2020T | FDA UDI | Class II | Active |
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