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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 24 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Estar-Z | ZTD4012T | FDA UDI | Class II | Active |
| Abutment Positioning Driver | HAPDL | FDA UDI | Class I | Active |
| OneGuide Twist Drill | OGTD2211 | FDA UDI | Class I | Active |
| US/SS/GS System | ERAR625CTH | FDA UDI | Class II | Active |
| SS SA Fixture | ASS3W5010S20 | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAR525 | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS2S4008S | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS3S4510S | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS4S4510S | FDA UDI | Class II | Active |
| SmartGuide Pin | SGP22 | FDA UDI | Class I | Active |
| US/SS/GS System | GS25FA5530NWH | FDA UDI | Class II | Active |
| Stopper | ODST15 | FDA UDI | Class I | Active |
| HS/HG Prosthetic System | HGCLSMT | FDA UDI | Class II | Active |
| US SA Implant System | AUS3M3513S | FDA UDI | Class II | Active |
| Osstem Implant System | TSSHA703RTH | FDA UDI | Class II | Active |
| US/SS/GS System | GSCA4840P | FDA UDI | Class II | Active |
| US Fixture Pick-up Impression Coping | ICSR500N | FDA UDI | Class I | Active |
| GS System | GSSAM3550D | FDA UDI | Class II | Active |
| Three Cutter Twist Drill | 3D3824T | FDA UDI | Class I | Active |
| Anchor Drill | HD4UAD11 | FDA UDI | Class I | Active |
| Bone Compaction Drill | BCD50055 | FDA UDI | Class I | Active |
| Multi Angled Abutment system | HGMAA330SHW | FDA UDI | Class II | Active |
| US/SS/GS System | CAR525 | FDA UDI | Class II | Active |
| GS System | GSFA4030N | FDA UDI | Class II | Active |
| US/SS/GS System | TMEW100TH | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS2M3518S | FDA UDI | Class II | Active |
| SMARTbuilder System | SMHI415USR | FDA UDI | Class II | Active |
| US/SS/GS System | CAR545WH | FDA UDI | Class II | Active |
| US/SS/GS System | TAAW6252CWH | FDA UDI | Class II | Active |
| US/SS/GS System | GSTA5710WH | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HUCMA50305RNW | FDA UDI | Class II | Active |
| US/SS/GS System | ERAR645CWH | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HUERA60407WPW | FDA UDI | Class II | Active |
| 123 Twist Drill | 2D304608LC | FDA UDI | Class I | Active |
| OneGuide Taper Drill | HOGTPD4513 | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTA3020T | FDA UDI | Class II | Active |
| Three Cutter Twist Drill | 3D3805T | FDA UDI | Class I | Active |
| US/SS/GS System | CAW614 | FDA UDI | Class II | Active |
| Pick-up Guide Pin | HGFPG05S | FDA UDI | Class I | Active |
| HS/HG Prosthetic System | HSSPC6004W | FDA UDI | Class II | Active |
| ET Prosthetic System | HGRGA4044MP | FDA UDI | Class II | Active |
| HS/HG Prosthetic System | HSEPC4807R | FDA UDI | Class II | Active |
| Remover Screw | HFRSRZ41F | FDA UDI | Class I | Active |
| SS SA Fixture | SS2R4013S18 | FDA UDI | Class II | Active |
| ET/SS Implant System | GSCAS4020P | FDA UDI | Class II | Active |
| SS SA Fixture | SS2R4515S18 | FDA UDI | Class II | Active |
| Perforation Drill | ORPED1505 | FDA UDI | Class I | Active |
| Estar-Z | ZP3B1025T | FDA UDI | Class II | Active |
| Guide | OGZB01S | FDA UDI | Class I | Active |
| HU/HS/HG Prosthetic System | HUERA60404WW | FDA UDI | Class II | Active |
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