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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 223 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ET/SS Implant System | SS3R4510S18 | FDA UDI | Class II | Active |
| Implant Driver | GSRFDL | EUDAMEDFDA UDI | Class I | Active |
| One485 Drill | HO4D5005WC | FDA UDI | Class I | Active |
| OneCAS Drill | OCD2810WC | FDA UDI | Class I | Active |
| OSSTEM Implant System | TSHA459R | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS2S5011S | FDA UDI | Class II | Active |
| ET/SS Implant System | SS3R4508S18 | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAR545N | FDA UDI | Class II | Active |
| Estar-Z | ZHTB4014M | FDA UDI | Class II | Active |
| OneGuide Taper Drill | OGTPD5008WC | FDA UDI | Class I | Active |
| OssBuilder System | OBAC351016 | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAW644NTH | FDA UDI | Class II | Active |
| US/SS/GS System | AAW6252CTH | FDA UDI | Class II | Active |
| Smartbrush 1 | OPISB1S | FDA UDI | Class I | Active |
| ET/SS Implant System | HGAGA502SNW | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | ETMTA503M | FDA UDI | Class II | Active |
| Estar-ZE | ZEHTB3020M | FDA UDI | Class II | Active |
| Ts Fixture System | TS3S6007S | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HGTFA50504SHW | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSTA6730NWH | FDA UDI | Class II | Active |
| SS Scan Body | SSNSBWLTH | FDA UDI | Class I | Active |
| Screw Removal Tip | HORTL | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | ASW200 | FDA UDI | Class II | Active |
| Estar-Z | ZHTA0016T | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | SSCAP6036CTH | FDA UDI | Class II | Active |
| US/SS/GS System | GSTA5640WH | FDA UDI | Class II | Active |
| OneGuide Accessory KIT | HOGAK | FDA UDI | Class I | Active |
| ET Prosthetic System | HGRGA4537MP | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS4S7010S | FDA UDI | Class II | Active |
| Estar-ZE | ZEHTD2020M | FDA UDI | Class II | Active |
| Estar-Z | ZSTB4016T | FDA UDI | Class II | Active |
| ET Prosthetic System | HGTFA4525SNW | FDA UDI | Class II | Active |
| MS SA Implant System | MSD3013S40 | FDA UDI | Class II | Active |
| Osstem Abutment System | GSTA6470WH | FDA UDI | Class II | Active |
| Posterior Guide | D4UPG0 | FDA UDI | Class I | Active |
| HU/HS/HG Prosthetic System | HUHCS35M | FDA UDI | Class II | Active |
| OneGuide Taper Drill | OGTPD5507SWC | FDA UDI | Class I | Active |
| AutoBone Collector | OABC304L | FDA UDI | Class I | Active |
| Estar-Z | ZHTC2014T | FDA UDI | Class II | Active |
| Estar-Z | ZHTD3010T | FDA UDI | Class II | Active |
| Estar-Z | ZP3D2018T | FDA UDI | Class II | Active |
| US/SS/GS System | GSTA6420WH | FDA UDI | Class II | Active |
| OsstemGuide Twist Drill | QGTD3613 | FDA UDI | Class I | Active |
| One485 Twist Drill | HO4D2205WC | FDA UDI | Class I | Active |
| Osstem Abutment System | TSMTB0405G | FDA UDI | Class II | Active |
| Bone Compaction Drill | BCD4511 | FDA UDI | Class I | Active |
| SideCut Drill | OSLMDS | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | MEM400 | FDA UDI | Class II | Active |
| Abutment Removal Tip | HOARTML | FDA UDI | Class I | Active |
| Estar-Z | ZHTD2010T | FDA UDI | Class II | Active |
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