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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 34 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Osstem Abutment System | GSTTA4010TH | FDA UDI | Class II | Active |
| GS System | GSSA3550O | FDA UDI | Class II | Active |
| Osstem Abutment System | TSPTA3570M | FDA UDI | Class II | Active |
| Taper Drill | TPD3C6007 | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTC4010T | FDA UDI | Class II | Active |
| OneGuide Twist Drill | HOGTD2210 | FDA UDI | Class I | Active |
| Estar-Z | ZSTD3020T | FDA UDI | Class II | Active |
| SMARTbuilder System | SMHI420USR | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS2S4015S | FDA UDI | Class II | Active |
| Adapter | TEADT | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | SSCAP4846C | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAW625NTH | FDA UDI | Class II | Active |
| Locator Torque Driver | TWLDL | FDA UDI | Class I | Active |
| Bone Profiler | ABPW700C | FDA UDI | Class I | Active |
| Twist Drill | 2D2023T | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTB4018M | FDA UDI | Class II | Active |
| Remover Screw | HFRSMS33F | FDA UDI | Class I | Active |
| SS SA Fixture | SS3R4013S28 | FDA UDI | Class II | Active |
| Ts Fixture System | BTS3S4010S | FDA UDI | Class II | Active |
| SMARTbuilder System | SMHA553R | FDA UDI | Class II | Active |
| HS/HG Prosthetic System | HGRTC5007S | FDA UDI | Class II | Active |
| SB Anchor | SBA401516 | FDA UDI | Class II | Active |
| SMARTbuilder System (SB1) | SM2W597SE | FDA UDI | Class II | Active |
| OneGuide Taper Drill | OGTPD3518 | FDA UDI | Class I | Active |
| Direct Drill | 3D6513FNLC | FDA UDI | Class I | Active |
| Taper KIT | OTSK | FDA UDI | Class I | Active |
| HS/HG Prosthetic System | HGRPC5005S | FDA UDI | Class II | Active |
| OneMS Drill | HOMD2713T | FDA UDI | Class I | Active |
| HU/HS/HG Prosthetic System | HUCMA70405WNW | FDA UDI | Class II | Active |
| ET/SS Implant System | GSCA6030P | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAW634TH | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS3S5013S | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS2S5008S | FDA UDI | Class II | Active |
| Estar-Z | ZP3D2012T | FDA UDI | Class II | Active |
| Estar-Z | ZTA0022T | FDA UDI | Class II | Active |
| US/SS/GS System | MTR200TH | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | SSERC485 | FDA UDI | Class II | Active |
| Estar-ZE | ZEHTB4014M | FDA UDI | Class II | Active |
| 122 Taper Drill Non Stopper | 122NTPD3511 | FDA UDI | Class I | Active |
| Estar-Z | ZP3A3014T | FDA UDI | Class II | Active |
| Estar-Z | ZSTD4020T | FDA UDI | Class II | Active |
| Resin Marker | RSMRKS | FDA UDI | Class I | Active |
| Excellent Solid Abutment Driver | HESDRL | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTA0016T | FDA UDI | Class II | Active |
| 122 Taper Drill | 122TPD5004 | FDA UDI | Class I | Active |
| Torque Driver for Denture | MSDTS | FDA UDI | Class I | Active |
| US SA Implant System | AUS2W5010S | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS2S4507S | FDA UDI | Class II | Active |
| Estar-Z | ZSTB2016T | FDA UDI | Class II | Active |
| Osstem Abutment System | GSTA5660WH | FDA UDI | Class II | Active |
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