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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 17 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ET US SS Prosthetic system | SSERC607 | FDA UDI | Class II | Active |
| Remover Body | FRKRBIS | FDA UDI | Class I | Active |
| SS SA Fixture | SS2W4511S20 | FDA UDI | Class II | Active |
| Bone Profiler | HGSBP70 | FDA UDI | Class I | Active |
| Taper KIT | OTSK | FDA UDI | Class I | Active |
| ET Prosthetic System | HGRGA6017SP | FDA UDI | Class II | Active |
| SMARTbuilder System (SB1) | SM2W6127SE | FDA UDI | Class II | Active |
| GS System | GSHAM457 | FDA UDI | Class II | Active |
| US/SS/GS System | GSTA5630WH | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HUHLA5103W | FDA UDI | Class II | Active |
| OneGuide Path Drill | OGSD2507W | FDA UDI | Class I | Active |
| 123 Twist Drill | 2D304108T | FDA UDI | Class I | Active |
| Bone Compaction Drill | BCD5008 | FDA UDI | Class I | Active |
| Plastic Scaler Connector | OICSCS2 | FDA UDI | Class I | Active |
| 122 Taper Drill | 122TPD4506 | FDA UDI | Class I | Active |
| 123 Cortical Drill | 2CD50 | FDA UDI | Class I | Active |
| GS System | GSFA4015 | FDA UDI | Class II | Active |
| SMARTbuilder System | SMHI510USP | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HSSDA4804RP | FDA UDI | Class II | Active |
| SS Excellent Solid Impression Coping | SSEIC485 | FDA UDI | Class I | Active |
| HU/HS/HG Prosthetic System | HGCPC60S | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS2S4007S | FDA UDI | Class II | Active |
| Cortical Drill 3 | HCD4C50 | FDA UDI | Class I | Active |
| Reamer Tip | HFRTS480 | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTB1010T | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | SSCRC485 | FDA UDI | Class II | Active |
| TSIII BA Fixture | TS3S4510B | FDA UDI | Class II | Active |
| Posterior Guide | D4UPG30 | FDA UDI | Class I | Active |
| US SA Implant System | AUS3R4010S | FDA UDI | Class II | Active |
| Osstem Abutment System | GSFSM | FDA UDI | Class II | Active |
| Bone Separator | OHST75 | FDA UDI | Class I | Active |
| OSSTEM Implant System | GSCS30 | FDA UDI | Class II | Active |
| Osstem Implant System | TSSHA605RTH | FDA UDI | Class II | Active |
| US/SS/GS System | GSCA4810P | FDA UDI | Class II | Active |
| Remover Screw | FRSRS41 | FDA UDI | Class I | Active |
| OSSTEM Implant System | BTS2M3508S | FDA UDI | Class II | Active |
| 123 Twist Drill | 2D304611T | FDA UDI | Class I | Active |
| Us/Ss/Gs System | ABFM213A | FDA UDI | Class II | Active |
| TS Transfer Impression Cap | GSTICRS | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS2S4013S | FDA UDI | Class II | Active |
| US/SS/GS System | EAR300TH | FDA UDI | Class II | Active |
| Estar-Z | ZHTA2014M | FDA UDI | Class II | Active |
| Estar-Z | ZHTC4018T | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HGTFA50505SHW | FDA UDI | Class II | Active |
| GS System | GSAA4320B | FDA UDI | Class II | Active |
| US/SS/GS System | CAR635NWH | FDA UDI | Class II | Active |
| 123 Twist Drill | 2D3036FNS | FDA UDI | Class I | Active |
| OSSTEM Implant System | BTS4S5007S | FDA UDI | Class II | Active |
| 122 Taper Drill | H122TPD5504 | FDA UDI | Class I | Active |
| Ts Fixture System | BTS2S5011S | FDA UDI | Class II | Active |
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