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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 2 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| US Fixture Transfer Impression Coping | ICPM402S | FDA UDI | Class I | Active |
| OSSTEM Implant System | BTS3S7006S | FDA UDI | Class II | Active |
| SS Excellent Solid Impression Cap | SSEIP600 | FDA UDI | Class I | Active |
| Orthodontic Screw Removal Tool | HSRT16H | FDA UDI | Class I | Active |
| TS Bite Impression Coping Driver | OICDMH | EUDAMEDFDA UDI | Class I | Active |
| OssBuilder System | SBCC4000 | FDA UDI | Class II | Active |
| US SA Implant System | US3P5011S | FDA UDI | Class II | Active |
| Estar-Z | ZP3C3010T | FDA UDI | Class II | Active |
| SS Excellent Solid Lab Analog | SSEA607 | FDA UDI | Class I | Active |
| OSSTEM Implant System - Abutment | GSRPC440 | FDA UDI | Class II | Active |
| US SA Implant System | AUS3P5011S | FDA UDI | Class II | Active |
| OneGuide SS Fixture Driver | OGFDW67S | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTA3014T | FDA UDI | Class II | Active |
| TS Implant Transfer Impression Coping | GSTIS4011 | FDA UDI | Class I | Active |
| OneGuide Taper Drill | OGTPD5508WC | FDA UDI | Class I | Active |
| Abutment removal tip | OARTM | FDA UDI | Class I | Active |
| Osstem Abutment System | GSTA4661NWH | FDA UDI | Class II | Active |
| Guide Screw | HKSBGS | FDA UDI | Class I | Active |
| HS/HG Prosthetic System | HSCOA6005WOW | FDA UDI | Class II | Active |
| Ts Fixture System | TS2S5011S | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAW617TH | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSRAS4751P | FDA UDI | Class II | Active |
| TS NoMount Driver | TSNMDCML | FDA UDI | Class I | Active |
| US/SS/GS System | GSTTA4030WH | FDA UDI | Class II | Active |
| Estar-Z | ZP9D4020T | FDA UDI | Class II | Active |
| One485 Drill (F4.5 Hard) | O4HD5005WC | FDA UDI | Class I | Active |
| OneMS Drill | OMD1813 | FDA UDI | Class I | Active |
| Osstem Abutment System | PTCMK | FDA UDI | Class II | Active |
| Countersink | USTCS45W | FDA UDI | Class I | Active |
| Estar-Z | ZP9A0010T | FDA UDI | Class II | Active |
| Estar-Z | ZP9C3014T | FDA UDI | Class II | Active |
| OneCAS Drill | HOCD3807WC | FDA UDI | Class I | Active |
| 123 Cortical Drill | O3CD50 | FDA UDI | Class I | Active |
| OsstemGuide Twist Drill | QGTD3010 | FDA UDI | Class I | Active |
| OneGuide KS NoMount Driver | HOGNMDR57K | FDA UDI | Class I | Active |
| Rigid Driver | HTR45L | FDA UDI | Class I | Active |
| ET Prosthetic System | HGTFA6034SNW | FDA UDI | Class II | Active |
| Ts Fixture System | GSCS35L | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS4S5011S | FDA UDI | Class II | Active |
| Prosthetic System | HGZAA553SHW | FDA UDI | Class II | Active |
| US/SS/GS System | CAW644WH | FDA UDI | Class II | Active |
| OneGuide Taper Drill | OGTPD3513T | FDA UDI | Class I | Active |
| One485 Drill | HO4D4008 | FDA UDI | Class I | Active |
| Machine Driver Handle | HMDH | FDA UDI | Class I | Active |
| Remover Screw | HFRSM35US | FDA UDI | Class I | Active |
| OneGuide Taper Drill | OGTPD4506 | FDA UDI | Class I | Active |
| Smartbrush 2 | OPISB27S | FDA UDI | Class I | Active |
| US Angled Abutment Selector | USAS005TH | FDA UDI | Class I | Active |
| Taper Drill | TPTD3C3507T | FDA UDI | Class I | Active |
| Orthodontic Screw Machine Driver | OSSMDA | FDA UDI | Class I | Active |
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