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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 35 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Taper Drill | TPD3C4506 | FDA UDI | Class I | Active |
| OssBuilder System | SBAC3505TSM | FDA UDI | Class II | Active |
| Taper Drill | HTPD3C3511 | FDA UDI | Class I | Active |
| US/SS/GS System | GSFA5515NWH | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAR437TH | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAR527N | FDA UDI | Class II | Active |
| NoMount Driver | USNMDRS | FDA UDI | Class I | Active |
| Scan Body | HGSBCRTH | FDA UDI | Class I | Active |
| Convertible Lab Analog | HGCLA60S | FDA UDI | Class I | Active |
| Twist Drill | QGTD3008 | FDA UDI | Class I | Active |
| 122 Taper Drill | H122TPD4010 | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | H122NTPD5007 | FDA UDI | Class I | Active |
| Estar-Z | ZTB3022T | FDA UDI | Class II | Active |
| Estar-ZE | ZEHTD2014M | FDA UDI | Class II | Active |
| ET Prosthetic System | HGRGA5044SP | FDA UDI | Class II | Active |
| Estar-Z | ZP9C1016T | FDA UDI | Class II | Active |
| OneCAS Drill | OCD3110W | FDA UDI | Class I | Active |
| US/SS/GS System | ERAW725CTH | FDA UDI | Class II | Active |
| Bone Compaction Drill | HBCD50055 | FDA UDI | Class I | Active |
| OneCAS Drill | HOCD3307 | FDA UDI | Class I | Active |
| Estar-Z | ZSTA1016T | FDA UDI | Class II | Active |
| ET/SS Implant System | SS3W5007S20 | FDA UDI | Class II | Active |
| Estar-Z | ZTA1012T | FDA UDI | Class II | Active |
| Estar-Z | ZP3D4010T | FDA UDI | Class II | Active |
| 123 Cortical Drill | 2CD45 | FDA UDI | Class I | Active |
| HU/HS/HG Prosthetic System | HUHLA6004W | FDA UDI | Class II | Active |
| GS System | GSGC400 | FDA UDI | Class II | Active |
| US/SS/GS System | ERAR527CWH | FDA UDI | Class II | Active |
| OneGuide Taper Drill | OGTPD3513W | FDA UDI | Class I | Active |
| 122 Taper Drill | 122TPD4005 | FDA UDI | Class I | Active |
| US/SS/GS System | CAW725 | FDA UDI | Class II | Active |
| US/SS/GS System | RGCW100WH | FDA UDI | Class II | Active |
| HySil Impression Materials | ESS50HD | FDA UDI | Class II | Active |
| Bone Compaction Drill | HBCD3511 | FDA UDI | Class I | Active |
| Estar-Z | ZSTA0018T | FDA UDI | Class II | Active |
| OneGuide Twist Drill | HOGTD1506W | FDA UDI | Class I | Active |
| GS system | GSHAS655 | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS4S4013S | FDA UDI | Class II | Active |
| Plastic Scaler Connector | HICSCS | FDA UDI | Class I | Active |
| Bone Compaction Drill | BCD4006 | FDA UDI | Class I | Active |
| Stopper | OSNST5 | FDA UDI | Class I | Active |
| Octa Abutment Driver | ODRL | FDA UDI | Class I | Active |
| OssBuilder System | SBHC5040 | FDA UDI | Class II | Active |
| Excellent Solid Driver | OTE48L | FDA UDI | Class I | Active |
| Prosthetic System | HGGCA451SNW | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS4S4011S | FDA UDI | Class II | Active |
| Taper Drill | TPD3C4006 | FDA UDI | Class I | Active |
| US/SS/GS System | TCAW5647NWH | FDA UDI | Class II | Active |
| OssBuilder System | OBAC533020 | FDA UDI | Class II | Active |
| Osteotome Stopper Set | HST25SH | FDA UDI | Class I | Active |
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