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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 4 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HU/HS/HG Prosthetic System | HUERA50305RW | FDA UDI | Class II | Active |
| Hiossen Prosthetic System | MGW200TH | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS4S4513S | FDA UDI | Class II | Active |
| One485 Drill (F4.5 Hard) | O4HD4508 | FDA UDI | Class I | Active |
| SS Excellent Solid Lab Analog | SSEA485 | FDA UDI | Class I | Active |
| US/SS/GS System | GSTTA4530WH | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSRRC441 | FDA UDI | Class II | Active |
| Estar-Z | ZSTB4020T | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | US17MAR4830TH | FDA UDI | Class II | Active |
| ET/SS Implant System | GSCAS4040P | FDA UDI | Class II | Active |
| OneMS Drill | HOMD1511 | FDA UDI | Class I | Active |
| OneGuide Path Drill | OGSD3013 | FDA UDI | Class I | Active |
| One485 Drill | O4HD5008WC | FDA UDI | Class I | Active |
| OneGuide Taper Drill | HGTPD4008SWC | FDA UDI | Class I | Active |
| HS/HG Prosthetic System | HSERC4805R | FDA UDI | Class II | Active |
| HS/HG Prosthetic System | HGRTC4004 | FDA UDI | Class II | Active |
| Estar-Z | ZP3C3022T | FDA UDI | Class II | Active |
| Estar-Z | ZP3A2025T | FDA UDI | Class II | Active |
| Estar-Z | ZSTA3010T | FDA UDI | Class II | Active |
| SS SA Fixture | ASS3R3513S18 | FDA UDI | Class II | Active |
| SS SA Fixture | SS2R4515S28 | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSZAS4550NWH | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | TSMA5020MP | FDA UDI | Class II | Active |
| 485 Drill | O485D4005 | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS4S5013S | FDA UDI | Class II | Active |
| ET/SS Implant System | HGAGA602SAW | FDA UDI | Class II | Active |
| GS System | GSRPC570 | FDA UDI | Class II | Active |
| Orthodontic Screw Machine Driver | OSSMDB | FDA UDI | Class I | Active |
| US/SS/GS System | AAM4252CWH | FDA UDI | Class II | Active |
| SS NoMount Torque Driver | SSNMT39S | FDA UDI | Class I | Active |
| SS ComOcta Impression Coping | SSCIC485 | FDA UDI | Class I | Active |
| Estar-Z | ZHTD2016M | FDA UDI | Class II | Active |
| SS SA Fixture | ASS3R3510S18 | FDA UDI | Class II | Active |
| Twist Drill | OSMSD27S | FDA UDI | Class I | Active |
| Np-Cast Abutment System | HSCNA60WNW | FDA UDI | Class II | Active |
| SB Anchor | SBA350516 | FDA UDI | Class II | Active |
| HS/HG Prosthetic System | HSCOA6004WOW | FDA UDI | Class II | Active |
| Ts Fixture System | TS2M3511S | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HUUGA4012MNW | FDA UDI | Class II | Active |
| US/SS/GS System | CAW625 | FDA UDI | Class II | Active |
| US/SS/GS System | GSRA4610P | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | SSERC604 | FDA UDI | Class II | Active |
| Bone Profiler | ABPM500C | FDA UDI | Class I | Active |
| Flattening Drill | HOGFD52SWC | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS3S7007S | FDA UDI | Class II | Active |
| ET Prosthetic System | HGTFA5035SNW | FDA UDI | Class II | Active |
| OsstemGuide Twist Drill | QGTD4607 | FDA UDI | Class I | Active |
| US/SS/GS System | GSRAS4420P | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HGTFA50205MHW | FDA UDI | Class II | Active |
| SB Anchor | SBA351016 | FDA UDI | Class II | Active |
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