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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 28 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| US/SS/GS System | ERAR514CTH | FDA UDI | Class II | Active |
| Cotical Drill 2 | HCD2C40 | FDA UDI | Class I | Active |
| Twist Drill | H485D2204 | FDA UDI | Class I | Active |
| Osstem Abutment System | GSST3530R | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HSEDA6007WP | FDA UDI | Class II | Active |
| SS SA Fixture | SS3R4508S28 | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS2S5018S | FDA UDI | Class II | Active |
| OsstemGuide Drill Guide | QGDG38W | FDA UDI | Class I | Active |
| SS SA Fixture | ASS2W5010S20 | FDA UDI | Class II | Active |
| OsstemGuide Tissue Punch | QGTP53W | FDA UDI | Class I | Active |
| OSSTEM Implant System - Abutment | GSRA4710P | FDA UDI | Class II | Active |
| Estar-Z | ZHTB4016T | FDA UDI | Class II | Active |
| Twist Drill | 3D3018FNLC | FDA UDI | Class I | Active |
| 485 Drill | H485D4508 | FDA UDI | Class I | Active |
| US SA Implant System | AUS2M3510S | FDA UDI | Class II | Active |
| Estar-Z | ZP9A2025T | FDA UDI | Class II | Active |
| Estar-Z | ZHTC2018T | FDA UDI | Class II | Active |
| OssBuilder System | SMHI310USM | FDA UDI | Class II | Active |
| ET/SS Implant System | GSCA4040P | FDA UDI | Class II | Active |
| Guide | OGNR03L | FDA UDI | Class I | Active |
| OSSTEM Implant System - Abutment | GSTA4751WH | FDA UDI | Class II | Active |
| SS Scan Body Screw | SSNSBSRL | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS4S6007S | FDA UDI | Class II | Active |
| Straight Fixture Surgical Tap | O2FTS45 | FDA UDI | Class I | Active |
| US/SS/GS System | GSFA7030NWH | FDA UDI | Class II | Active |
| OneGuide Twist Drill | OGTD2210T | FDA UDI | Class I | Active |
| HS/HG Prosthetic System | HGSTA353S | FDA UDI | Class II | Active |
| SS SA Fixture | ASS3WB6010S20 | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAW715NTH | FDA UDI | Class II | Active |
| SS SA Fixture | ASS2R4010S18 | FDA UDI | Class II | Active |
| US SA Implant System | US3M3511S | FDA UDI | Class II | Active |
| US System | MGS200 | FDA UDI | Class II | Active |
| Remover Screw | FRKCSE20LJ2 | FDA UDI | Class I | Active |
| US/GS Ultra Wide System | GSRA8640P | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | SSEC607 | FDA UDI | Class II | Active |
| Estar-Z | ZP9C4016T | FDA UDI | Class II | Active |
| Multi Angled Abutment system | HGMAA430MHW | FDA UDI | Class II | Active |
| Osstem Abutment System | GSTTA4510NTH | FDA UDI | Class II | Active |
| SS SA Fixture | ASS3R3510S28 | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAW715TH | FDA UDI | Class II | Active |
| Estar-Z | ZTA4014T | FDA UDI | Class II | Active |
| Osstem Abutment System | USPTA4050R | FDA UDI | Class II | Active |
| US Esthetic Lab Analog | ERR300 | FDA UDI | Class I | Active |
| HS/HG Prosthetic System | HSCOA6007WNW | FDA UDI | Class II | Active |
| US/SS/GS System | CAR525TH | FDA UDI | Class II | Active |
| US/SS/GS System | ERAR535CWH | FDA UDI | Class II | Active |
| Osstem Abutment System | TS30PA455MWH | EUDAMEDFDA UDI | Class II | Active |
| SS SA Fixture System | SS2W5011S20 | FDA UDI | Class II | Active |
| Prosthetic System | GSGA4010S | FDA UDI | Class II | Active |
| Orthodontic Screw System | OSTH1808 | FDA UDI | Class II | Active |
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