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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 22 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Osstem Abutment System | USPTA4070R | FDA UDI | Class II | Active |
| SS SA Fixture | SS3R4008S18 | FDA UDI | Class II | Active |
| SS SA Fixture | ASS3WB7007S20 | FDA UDI | Class II | Active |
| SS SA Fixture | ASS2R4008S28 | FDA UDI | Class II | Active |
| Osstem Abutment System | GSTAS4771NWH | FDA UDI | Class II | Active |
| SS SA Fixture | ASS3W5013S20 | FDA UDI | Class II | Active |
| BP Guide Distance Setup Pin | PGDSP | FDA UDI | Class I | Active |
| SS Scan Body | SSNSBRLTH | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | SSS484P | FDA UDI | Class II | Active |
| Estar-ZE | ZEHTA4022T | FDA UDI | Class II | Active |
| Taper Drill | TPD3C5011 | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | SSCA607N | FDA UDI | Class II | Active |
| US Angled Abutment Selector | USAS003TH | FDA UDI | Class I | Active |
| Rigid Driver | HTR60L | FDA UDI | Class I | Active |
| Bone Profiler | GSBP60 | FDA UDI | Class I | Active |
| Bone Compaction Drill | BCD4004 | FDA UDI | Class I | Active |
| SS Octa Lab Analog | SSLA480 | FDA UDI | Class I | Active |
| HU/HS/HG Prosthetic System | HGTFA70205SNW | FDA UDI | Class II | Active |
| Cortical Drill 2 | CD2C35 | FDA UDI | Class I | Active |
| Remover Screw | FRSRI40F | FDA UDI | Class I | Active |
| Stopper | HOCDS07W | FDA UDI | Class I | Active |
| HUII/HSII Fixture System | HUCS41R | FDA UDI | Class II | Active |
| Taper Cortical Drill | HTCD4C55 | FDA UDI | Class I | Active |
| Estar-Z | ZP3C4014T | FDA UDI | Class II | Active |
| Estar-Z | ZHTB3025T | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HUHLA5007R | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HUAGA50225RHW | FDA UDI | Class II | Active |
| US/SS/GS System | ERAR517CWH | FDA UDI | Class II | Active |
| ET Prosthetic System | HGTFA7035SHW | FDA UDI | Class II | Active |
| SMARTbuilder System | SMHI320USM | FDA UDI | Class II | Active |
| US/SS/GS System | CAR524 | FDA UDI | Class II | Active |
| HS/HG Prosthetic System | HSSRC6004W | FDA UDI | Class II | Active |
| US/SS/GS System | CAW615WH | FDA UDI | Class II | Active |
| US/SS/GS System | MER300TH | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HUERA60405WW | FDA UDI | Class II | Active |
| US/SS/GS System | TAR200TH | FDA UDI | Class II | Active |
| Guide | OGUWS | FDA UDI | Class I | Active |
| Osstem Abutment System | USPTA5040W | FDA UDI | Class II | Active |
| SS System | SSRA200 | FDA UDI | Class II | Active |
| MS SA Implant System | MSN2510S25 | FDA UDI | Class II | Active |
| Orthodontic Screw Machine Driver | HOSSMDA | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS3S7008S | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAW625TH | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSRA7640P | FDA UDI | Class II | Active |
| Estar-Z | ZP3C2018T | FDA UDI | Class II | Active |
| TS Rigid Lab Analog | GSRLA670 | FDA UDI | Class I | Active |
| TS Implant Transfer Impression Coping | GSTIM4514 | FDA UDI | Class I | Active |
| OSSTEM Implant System - Abutment | GSRAS4440P | FDA UDI | Class II | Active |
| SS SA Fixture System | SS3W6011S20 | FDA UDI | Class II | Active |
| Osstem Implant Co., Ltd. | SNAP Wireless | FDA UDI | Class II | Active |
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