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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 21 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OsstemGuide Twist Drill | QGTD3607 | FDA UDI | Class I | Active |
| Osstem Abutment System | SSPTA4850R | FDA UDI | Class II | Active |
| OneGuide Implant Anchor | HOGFAKR | FDA UDI | Class I | Active |
| TS Convertible Lab Analog | GSCLA400 | FDA UDI | Class I | Active |
| 123 Twist Drill | 2D3046L | FDA UDI | Class I | Active |
| US/SS/GS System | CAR625 | FDA UDI | Class II | Active |
| Ridge Split Chisel | HRSO15 | FDA UDI | Class I | Active |
| Reamer Bite | HFRBC | FDA UDI | Class I | Active |
| HU/HS/HG Prosthetic System | HUERA60207WPW | FDA UDI | Class II | Active |
| ET/SS Implant System | SS2W4513S20 | FDA UDI | Class II | Active |
| US/SS/GS System | GSRA5610P | FDA UDI | Class II | Active |
| Guide | OGZB02L | FDA UDI | Class I | Active |
| OsstemGuide TS Mount | QGHGMR | FDA UDI | Class I | Active |
| KS NoMount Driver | KSNMDCRS | FDA UDI | Class I | Active |
| Orthodontic Screw Removal Tool | OSRT18E | FDA UDI | Class I | Active |
| Estar-Z | ZP9D2016T | FDA UDI | Class II | Active |
| Bone Compaction Drill | HBCD3511 | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | 122NTPD4004 | FDA UDI | Class I | Active |
| Osstem Implant System | TSSHA455RB | FDA UDI | Class II | Active |
| Orthodontic Screw Removal Tool | OSRT12E | FDA UDI | Class I | Active |
| US/SS/GS System | GSAA4340BWH | FDA UDI | Class II | Active |
| ET/SS Implant System | ASS2R4513S18 | FDA UDI | Class II | Active |
| US Standard Lab Analog | SRR300 | FDA UDI | Class I | Active |
| Orthodontic Screw System | OSTH1606 | FDA UDI | Class II | Active |
| Plastic Scaler Connector | HICSCE2 | FDA UDI | Class I | Active |
| Membrane Lifter | SNML4113TL | FDA UDI | Class I | Active |
| Osstem Abutment System | GSMABSS | FDA UDI | Class II | Active |
| One485 Pilot Drill | O4D3506 | FDA UDI | Class I | Active |
| Perforation Drill | ORPUD1507 | FDA UDI | Class I | Active |
| OSSTEM Implant System - Abutment | GSRPC540 | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSRAS4640P | FDA UDI | Class II | Active |
| Taper Drill | HTPD3C5511 | FDA UDI | Class I | Active |
| OneMS Lance Drill | HOMLD1513 | FDA UDI | Class I | Active |
| US/SS/GS System | AAR5254CTH | FDA UDI | Class II | Active |
| Bone Compaction Drill | BCD3508 | FDA UDI | Class I | Active |
| SS SA Fixture | SS3R4008S28 | FDA UDI | Class II | Active |
| SS SA Fixture | ASS2R4511S18 | FDA UDI | Class II | Active |
| Osstem Abutment System | TSPTA3510M | FDA UDI | Class II | Active |
| US/SS/GS System | TGCW100TH | FDA UDI | Class II | Active |
| Remover Body | FRKRBIL | FDA UDI | Class I | Active |
| Prosthetic System | HGSAD351M | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HGTFA60305SHW | FDA UDI | Class II | Active |
| OneGuide Taper Drill | OGTPD3506 | FDA UDI | Class I | Active |
| US/SS/GS System | GSCA4830P | FDA UDI | Class II | Active |
| Estar-Z | ZP9A1022T | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS3M3513S | FDA UDI | Class II | Active |
| Osstem Abutment System | GSST3550R | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS4S4011S | FDA UDI | Class II | Active |
| One485 Twist Drill | O4D2206WC | FDA UDI | Class I | Active |
| Osstem Implant System | TSSHA604RB | FDA UDI | Class II | Active |
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