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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 5 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HS/HG Prosthetic System | HSCOA6005WNW | FDA UDI | Class II | Active |
| SS SA Fixture System | SS3R4513S28 | FDA UDI | Class II | Active |
| Ts Fixture System | TS2S4508S | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | TCAW647TH | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | TCAW627TH | FDA UDI | Class II | Active |
| MS SA Implant System | MSD3013S20 | FDA UDI | Class II | Active |
| GS Convertible Pick-up Guide Pin | GSCGP480S | FDA UDI | Class I | Active |
| Remover Body | FRKRBE35L | FDA UDI | Class I | Active |
| Prosthetic System | HGSAD354M | FDA UDI | Class II | Active |
| Estar-ZE | ZEHTD2010T | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | NMTR200TH | FDA UDI | Class II | Active |
| Three Cutter Twist Drill | 3D3311LC01 | FDA UDI | Class I | Active |
| OssBuilder System | OBAC350516 | FDA UDI | Class II | Active |
| Orthodontic Screw System | OSTH1610 | FDA UDI | Class II | Active |
| US/SS/GS System | GSRAS4740P | FDA UDI | Class II | Active |
| OneCAS Drill | OCD3610 | FDA UDI | Class I | Active |
| US/GS Ultra Wide System | GSRA7630P | FDA UDI | Class II | Active |
| US System | OAO200 | FDA UDI | Class II | Active |
| OneGuide Taper Cortical Drill | OGTCD4510 | FDA UDI | Class I | Active |
| Osstem Abutment System | GSTA4761WH | FDA UDI | Class II | Active |
| OssBuilder System | SBAC4020TSR | FDA UDI | Class II | Active |
| Estar-Z | ZP3A3525T | FDA UDI | Class II | Active |
| US SA Implant System | AUS2P5013S | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | OAAW400 | FDA UDI | Class II | Active |
| US/SS/GS System | GCR100TH | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS4S4507S | FDA UDI | Class II | Active |
| Three Cutter Twist Drill | 3D3810LC01 | FDA UDI | Class I | Active |
| BP Guide Distance Setup Pin | HPGDSP | FDA UDI | Class I | Active |
| US/SS/GS System | RASW200W | FDA UDI | Class II | Active |
| 122 Taper Drill | 122TPD6006 | FDA UDI | Class I | Active |
| 122 Taper Drill | H122TPD4511 | FDA UDI | Class I | Active |
| SS SA Fixture | SS3R3513S28 | FDA UDI | Class II | Active |
| SS SA Fixture | ASS2R4510S18 | FDA UDI | Class II | Active |
| Estar-Z | ZHTC3010T | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSTA4651NWH | FDA UDI | Class II | Active |
| Estar-Z | ZP9B3016T | FDA UDI | Class II | Active |
| US NoMount Driver | USNMD51WL | FDA UDI | Class I | Active |
| Three Cutter Twist Drill | 3D3322T | FDA UDI | Class I | Active |
| TS Implant Pick-up Impression Coping | GSPIS4015 | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | H122NTPD5010 | FDA UDI | Class I | Active |
| SS SA Fixture | SS2R4507S18 | FDA UDI | Class II | Active |
| US SA Implant System | US3R4008S | FDA UDI | Class II | Active |
| OssBuilder System | OBAC352016 | FDA UDI | Class II | Active |
| Perforation Drill | ORPMD1503 | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | CAW647NTH | FDA UDI | Class II | Active |
| 122 Taper Drill | 122TPD4015 | FDA UDI | Class I | Active |
| MS Narrow Ridge Implant Driver | HOGFDMSN | FDA UDI | Class I | Active |
| US Fixture Pick-up Guide Pin | CSM150 | FDA UDI | Class I | Active |
| Osstem Abutment System | TS17PA454RWH | EUDAMEDFDA UDI | Class II | Active |
| SS SA Fixture | ASS2W5011S20 | FDA UDI | Class II | Active |
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