Is this your brand? Sign in to claim ownership.
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 33 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Reverse Drill | ARVDRSC | FDA UDI | Class I | Active |
| OSSTEM Implant System - Abutment | GSZAS5535NWH | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAW635NTH | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HGTFA50105MNW | FDA UDI | Class II | Active |
| SS SA Fixture | SS3R4508S18 | FDA UDI | Class II | Active |
| HySil Plus Impression Materials | ESS50MSD | FDA UDI | Class II | Active |
| 122 Taper Drill | 122TPD4505 | FDA UDI | Class I | Active |
| Taper Drill | TPD3C3508 | FDA UDI | Class I | Active |
| ET/SS Implant System | HGTFA5025MNW | FDA UDI | Class II | Active |
| SS SA Fixture | SS3R4510S28 | FDA UDI | Class II | Active |
| Estar-ZE | ZEHTA1022M | FDA UDI | Class II | Active |
| US SA Implant System | US3M3508S | FDA UDI | Class II | Active |
| SS SA Fixture | SS3R3508S28 | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSTA7620NWH | FDA UDI | Class II | Active |
| 122 Taper Drill | H122TPD4515 | FDA UDI | Class I | Active |
| Us System | AIHM405 | FDA UDI | Class II | Active |
| Locator Torque Driver | OTWLDS | FDA UDI | Class I | Active |
| HySil Plus Impression Materials | ESS50MSB | FDA UDI | Class II | Active |
| HS/HG Prosthetic System | SSTCO600 | FDA UDI | Class II | Active |
| OSSTEM Implant System | TSHA707R | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS4S6008S | FDA UDI | Class II | Active |
| Screw Holder | OSHW | FDA UDI | Class I | Active |
| Taper Drill | HTPD3C5013 | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | H122NTPD7010 | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS4S6011S | FDA UDI | Class II | Active |
| OneCAS Drill | OCD2807WC | FDA UDI | Class I | Active |
| Estar-Z | ZTA1020T | FDA UDI | Class II | Active |
| Taper Drill | TPD3C5513 | FDA UDI | Class I | Active |
| 122 Taper Drill | H122TPD4015 | FDA UDI | Class I | Active |
| 123 Twist Drill | 3D465206T | FDA UDI | Class I | Active |
| US Standard Polishing Protector | SPCR100 | FDA UDI | Class I | Active |
| OsstemGuide Drill Guide | QGDG20M | FDA UDI | Class I | Active |
| 122 Taper Drill | 122TPD3505 | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS2S4508S | FDA UDI | Class II | Active |
| Osstem Abutment System | GSTA5760NWH | FDA UDI | Class II | Active |
| Estar-Z | ZHTA1012T | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | US30MAR4840TH | FDA UDI | Class II | Active |
| US/SS/GS System | GSRA6620P | FDA UDI | Class II | Active |
| OneCAS Drill | OCD3307W | FDA UDI | Class I | Active |
| Bone Compaction Drill | HBCD3505 | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS2S4010S | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSRA5640P | FDA UDI | Class II | Active |
| Expansion Drill | OEXP223610 | FDA UDI | Class I | Active |
| Estar-Z | ZP9C4012T | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAR535TH | FDA UDI | Class II | Active |
| Membrane Lifter | SNML3613TS | FDA UDI | Class I | Active |
| Osstem Abutment System | USPTA3540M | FDA UDI | Class II | Active |
| ET/SS Implant System | SS3W5011S20 | FDA UDI | Class II | Active |
| US SA Implant System | AUS3W5015S | FDA UDI | Class II | Active |
| OsstemGuide Drill Guide | QGDG41R | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.