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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 11 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Depth Gauge | HCDG | FDA UDI | Class I | Active |
| US/SS/GS System | GSTA6720NWH | FDA UDI | Class II | Active |
| Twist Drill | 2D2023T | FDA UDI | Class I | Active |
| ET Prosthetic System | HGRGA4555SP | FDA UDI | Class II | Active |
| US/SS/GS System | CAR514TH | FDA UDI | Class II | Active |
| SideCut Drill | OSLMDL | FDA UDI | Class I | Active |
| OSSTEM Implant System - Abutment | GSRA4651P | FDA UDI | Class II | Active |
| Taper Drill | HTPD3C7010 | FDA UDI | Class I | Active |
| OneGuide Twist Drill | HOGTD2213T | FDA UDI | Class I | Active |
| OSSTEM Implant System - Abutment | GSRPC660 | FDA UDI | Class II | Active |
| Ts Fixture System | BTS3S5007S | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HUHLA7005W | FDA UDI | Class II | Active |
| Stopper | HOCDS01W | FDA UDI | Class I | Active |
| US System | RASW300 | FDA UDI | Class II | Active |
| US/SS/GS System | SSCA604TH | FDA UDI | Class II | Active |
| US/SS/GS System | GSCPL480WH | FDA UDI | Class II | Active |
| Estar-ZE | ZEHTA1020M | FDA UDI | Class II | Active |
| US SA Implant System | AUS2R4008S | FDA UDI | Class II | Active |
| OssBuilder System | OBAC531520 | FDA UDI | Class II | Active |
| TS Bite Index | GSBIM4512S | FDA UDI | Class I | Active |
| US Implant Lab Analog | FAM300 | FDA UDI | Class I | Active |
| SS SA Fixture | ASS3R4008S18 | FDA UDI | Class II | Active |
| GS System | GS25FA4030N | FDA UDI | Class II | Active |
| US/SS/GS System | CAW614TH | FDA UDI | Class II | Active |
| US/SS/GS System | CAR515WH | FDA UDI | Class II | Active |
| US/SS/GS System | AAM4154CWH | FDA UDI | Class II | Active |
| 122 Taper Drill | 122TPD5510 | FDA UDI | Class I | Active |
| OneGuide Taper Drill | HOGTPD5513WC | FDA UDI | Class I | Active |
| 485 Drill | O485D4506 | FDA UDI | Class I | Active |
| OneGuide Reamer Drill | OGRDS51 | FDA UDI | Class I | Active |
| Mount Driver | HOGMDW | FDA UDI | Class I | Active |
| US/SS/GS System | GSGA4010SWH | FDA UDI | Class II | Active |
| 122 Taper Drill | H122TPD4004 | FDA UDI | Class I | Active |
| US/SS/GS System | SSA6015WH | FDA UDI | Class II | Active |
| US/SS/GS System | TASW200W | FDA UDI | Class II | Active |
| HySil Plus Impression Materials | ESS380MS | FDA UDI | Class II | Active |
| 122 Taper Drill | H122TPD4008 | FDA UDI | Class I | Active |
| Perforation Drill | ORPMD2003 | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTD4012M | FDA UDI | Class II | Active |
| Ts Fixture System | TS3S7008S | FDA UDI | Class II | Active |
| SMARTbuilder System | SMHI515USP | FDA UDI | Class II | Active |
| US/SS/GS System | GSTA5420WH | FDA UDI | Class II | Active |
| GS System | GSHAM553 | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS3S6008S | FDA UDI | Class II | Active |
| US/SS/GS System | OAA500D | FDA UDI | Class II | Active |
| ET Prosthetic System | HGTFA6025SNW | FDA UDI | Class II | Active |
| US/SS/GS System | SSCA604NTH | FDA UDI | Class II | Active |
| US/SS/GS System | CAW745NTH | FDA UDI | Class II | Active |
| 485 Kit | O485K | FDA UDI | Class I | Active |
| Osstem Implant System | TSSHA453MTH | FDA UDI | Class II | Active |
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