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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 27 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Torque Driver For Torque Wrench | TRSD05S | FDA UDI | Class I | Active |
| US/SS/GS System | SSCA484NWH | FDA UDI | Class II | Active |
| ET/SS Implant System | SS2W5006S20 | FDA UDI | Class II | Active |
| US Standard Transfer Impression Coping | STR100 | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | OAAW500 | FDA UDI | Class II | Active |
| Osstem Abutment System | GSTA4632WH | FDA UDI | Class II | Active |
| Estar-Z | ZSTA3518T | FDA UDI | Class II | Active |
| US Fixture Pick-up Impression Coping | ICFR600 | FDA UDI | Class I | Active |
| US/SS/GS System | CAR645NTH | FDA UDI | Class II | Active |
| US/SS/GS System | TCAW5647N | FDA UDI | Class II | Active |
| 123 Twist Drill | 3D465510LC | FDA UDI | Class I | Active |
| Expansion Drill | OEXP324710 | FDA UDI | Class I | Active |
| Estar-Z | ZSTB4010T | FDA UDI | Class II | Active |
| HySil Impression Materials (Heavy, Mono, and Bite) | ESS380H | FDA UDI | Class II | Active |
| Taper Parallel Pin | HTPP4522 | FDA UDI | Class I | Active |
| OssBuilder System | SMHI320USM | FDA UDI | Class II | Active |
| Mambrane Lifter | OSNML3613TL | FDA UDI | Class I | Active |
| OSSTEM Implant System | BTS3S4013S | FDA UDI | Class II | Active |
| Estar-Z | ZSTB2025T | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS3S7013S | FDA UDI | Class II | Active |
| Us/Ss/Gs System | AUS3R413AR | FDA UDI | Class II | Active |
| TS Scan body | TSSBMTH | FDA UDI | Class I | Active |
| Fixture Transfer Impression Coping | HGFTI4514MN | FDA UDI | Class I | Active |
| SS SA Fixture | ASS2W4508S20 | FDA UDI | Class II | Active |
| TSIII BA Fixture | BTS3S4507B | FDA UDI | Class II | Active |
| Taper Drill | TPTD3C3515T | FDA UDI | Class I | Active |
| Estar-Z | ZHTA4022M | FDA UDI | Class II | Active |
| US SA Implant System | US3P5007S | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSZAS4550WH | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | MEM200 | FDA UDI | Class II | Active |
| Membrane Lifter | SNML2813TL | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTD2012M | FDA UDI | Class II | Active |
| ET/SS Implant System | HGTFA5045MNW | FDA UDI | Class II | Active |
| US SA Implant System | AUS3M3511S | FDA UDI | Class II | Active |
| Port Multi Tool | HPTCMT | FDA UDI | Class I | Active |
| Taper Drill | TPD3C6008 | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS4S4015S | FDA UDI | Class II | Active |
| Prosthetic System | GSCAM23N | FDA UDI | Class II | Active |
| Mambrane Lifter | OSNML3113TL | FDA UDI | Class I | Active |
| US SA Implant System | AUS3W5013S | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | RCAW627 | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HGCLSSW | FDA UDI | Class II | Active |
| SS SA Fixture | ASS3R4513S18 | FDA UDI | Class II | Active |
| US Implant Transfer Impression Coping | ICPW602S | FDA UDI | Class I | Active |
| OneGuide Path Drill | OGSD2513 | FDA UDI | Class I | Active |
| SMARTbuilder System | SM3W10127SB | FDA UDI | Class II | Active |
| NoMount Driver | SSNMDE | FDA UDI | Class I | Active |
| Estar-Z | ZTA3010T | FDA UDI | Class II | Active |
| Excellent Solid Driver | OTE48S | FDA UDI | Class I | Active |
| Taper Drill | HTPD3C4011 | FDA UDI | Class I | Active |
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