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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 31 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HU/HS/HG Prosthetic System | HUERA70105WW | FDA UDI | Class II | Active |
| US/SS/GS System | ERAR645C | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSRRC461 | FDA UDI | Class II | Active |
| One485 Drill | O4D5008WC | FDA UDI | Class I | Active |
| SMARTbuilder System | SMHI410E | FDA UDI | Class II | Active |
| Trial Pin | HUWFTP55 | FDA UDI | Class I | Active |
| 122 Taper Drill | H122TPD5505 | FDA UDI | Class I | Active |
| Orthodontic Screw Driver Tip | HOSSDT | FDA UDI | Class I | Active |
| Estar-Z | ZHTC4022M | FDA UDI | Class II | Active |
| OssBuilder System | SMHI525USW | FDA UDI | Class II | Active |
| Direct Drill | 3D6513FNLC | FDA UDI | Class I | Active |
| Taper Fixture Surgical Tap | HFTS50 | FDA UDI | Class I | Active |
| ET Selection KIT | HTSKCA | FDA UDI | Class I | Active |
| Bone Compaction Drill | BCDI04 | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | TCAW647NTH | FDA UDI | Class II | Active |
| ET Prosthetic System | HGRGA5025SP | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HGTFA45505MNW | FDA UDI | Class II | Active |
| US/SS/GS System | SSFSW | FDA UDI | Class II | Active |
| US SA Implant System | US2P5007S | FDA UDI | Class II | Active |
| OneGuide KS Implant Driver | OGFDR57K | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTA3520T | FDA UDI | Class II | Active |
| Estar-ZE | ZEHTA1020T | FDA UDI | Class II | Active |
| US SA Implant System | US2W5011S | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HUCMA60207WNPW | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HGCTC4010NW | FDA UDI | Class II | Active |
| US/SS/GS System | RPSW200TH | FDA UDI | Class II | Active |
| SS SA Fixture | SS3R4510S18 | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS3M3015S | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAR537 | FDA UDI | Class II | Active |
| SS SA Fixture | ASS2W5006S20 | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSRRC560 | FDA UDI | Class II | Active |
| TS Implant Pick-up Impression Coping | GSPIS4011N | FDA UDI | Class I | Active |
| Remover Screw | FRSRA40F | FDA UDI | Class I | Active |
| Osteotome Stopper Set | HST35SH | FDA UDI | Class I | Active |
| Osstem Abutment System | GSTTA4030TH | FDA UDI | Class II | Active |
| US Implant Transfer Impression Coping | ICPR502L | FDA UDI | Class I | Active |
| US SA Implant System | AUS3P5013S | FDA UDI | Class II | Active |
| GS System | GSFAM4015N | FDA UDI | Class II | Active |
| Estar-Z | ZHTD3025M | FDA UDI | Class II | Active |
| Taper Drill | HTPD3C5015 | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS2S4018S | FDA UDI | Class II | Active |
| OneGuide Twist Drill | OGTD2207S | FDA UDI | Class I | Active |
| Twist Drill | H2D2018FNLC | FDA UDI | Class I | Active |
| OneCAS Drill | OCD4107WC | FDA UDI | Class I | Active |
| OneGuide TS Implant Driver | HOGFDRH57 | FDA UDI | Class I | Active |
| HU/HS/HG Prosthetic System | HGRGA40307SP | FDA UDI | Class II | Active |
| OneGuide Path Drill | OGSD2507T | FDA UDI | Class I | Active |
| Ts Fixture System | BTS3S7008S | FDA UDI | Class II | Active |
| US/SS/GS System | AAR5152CWH | FDA UDI | Class II | Active |
| Guide | HOGUWL | FDA UDI | Class I | Active |
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