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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 6 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ET US SS Prosthetic system | SSCAP4846CNTH | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS2S4507S | FDA UDI | Class II | Active |
| Changeable Torque wrench | TW30CB | FDA UDI | Class I | Active |
| Ridge Split Chisel | ORSO20 | FDA UDI | Class I | Active |
| Bone Profiler | KSBP50 | FDA UDI | Class I | Active |
| SS Implant Pick-up Impression Coping | SSICAS600N | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | CAW624 | FDA UDI | Class II | Active |
| MS Lab Analog Denture | MSDLA | FDA UDI | Class I | Active |
| OsstemGuide Initial Drill | QGID20M | FDA UDI | Class I | Active |
| HU/HS/HG Prosthetic System | HUSAO502R | FDA UDI | Class II | Active |
| OneGuide Taper Drill | OGTPD4018WC | FDA UDI | Class I | Active |
| Tissue Punch | OGTP30R | FDA UDI | Class I | Active |
| Orthodontic Screw Removal Tool | OSRT14E | FDA UDI | Class I | Active |
| ET/SS Implant System | ASS2W5013S20 | FDA UDI | Class II | Active |
| OneGuide Taper Drill | OGTPD4008SWC | FDA UDI | Class I | Active |
| 122 Taper Drill | 122TPD6006 | FDA UDI | Class I | Active |
| ET/SS Implant System | SS3R4007S18 | FDA UDI | Class II | Active |
| US/SS/GS System | ERAR537CTH | FDA UDI | Class II | Active |
| OneGuide KIT | OOGK | FDA UDI | Class I | Active |
| OssBuilder System | OBAC431520A | FDA UDI | Class II | Active |
| TS Rigid Lab Analog | GSRLA570 | FDA UDI | Class I | Active |
| OneGuide Taper Drill | OGTPD4015 | FDA UDI | Class I | Active |
| Trephine Drill | TD57 | FDA UDI | Class I | Active |
| GS System | GSTTA4010N | FDA UDI | Class II | Active |
| US SA Implant System | AUS3R4507S | FDA UDI | Class II | Active |
| SS System | SSRA400 | FDA UDI | Class II | Active |
| SS ComOcta Lab Analog | SSCLA607 | FDA UDI | Class I | Active |
| ET Prosthetic System | HGRGA4055SP | FDA UDI | Class II | Active |
| Remover Screw | FRSW50 | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS2M3515S | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS3S4515S | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS4S4010S | FDA UDI | Class II | Active |
| SS System | SSRA200S | FDA UDI | Class II | Active |
| SS ComOcta Lab Analog | SSCLA485 | FDA UDI | Class I | Active |
| US/SS/GS System | SAR400TH | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAR514NTH | FDA UDI | Class II | Active |
| SS Excellent Solid Lab Analog | SSEA485 | FDA UDI | Class I | Active |
| Taper Cortical Drill | HTCD4C45 | FDA UDI | Class I | Active |
| Straight Fixture Surgical Tap | O2FTS50 | FDA UDI | Class I | Active |
| ET Prosthetic System | HGTFA4517MHW | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSTA5630NWH | FDA UDI | Class II | Active |
| ET Prosthetic System | HGTFA4555MNW | FDA UDI | Class II | Active |
| OssBuilder System | OBAC402018 | FDA UDI | Class II | Active |
| Estar-Z | ZHTA3510T | FDA UDI | Class II | Active |
| 123 Twist Drill | 3D465513T | FDA UDI | Class I | Active |
| US/SS/GS System | ERAW645CTH | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | SSE607P | FDA UDI | Class II | Active |
| 122 Taper Drill | 122TPD5504 | FDA UDI | Class I | Active |
| OneGuide NoMount Driver | HOGNMDM50 | FDA UDI | Class I | Active |
| Taper Drill | TPD3C3510 | FDA UDI | Class I | Active |
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