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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 19 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mambrane Lifter | OSNML2813TL | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS3M3015S | FDA UDI | Class II | Active |
| Guide | OGNR04S | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | CAW635TH | FDA UDI | Class II | Active |
| US/SS/GS System | AAW6152CTH | FDA UDI | Class II | Active |
| US/SS/GS System | ERAW625CTH | FDA UDI | Class II | Active |
| US Fixture Transfer Impression Coping | ICPW602L | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | SSCA604 | FDA UDI | Class II | Active |
| Rigid Driver | OTR45S | FDA UDI | Class I | Active |
| OneGuide Taper Drill | HOGTPD4010 | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTA3014M | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS3S4510S | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | ZAM557TH | FDA UDI | Class II | Active |
| Estar-Z | ZTA0025T | FDA UDI | Class II | Active |
| Bone Compaction Drill | BCD3508 | FDA UDI | Class I | Active |
| Posterior Guide | HD4UPG17 | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTB2014M | FDA UDI | Class II | Active |
| Expansion Drill | EXP284410 | FDA UDI | Class I | Active |
| US/SS/GS System | AAM4154CTH | FDA UDI | Class II | Active |
| OneMS Drill | OMD2310 | FDA UDI | Class I | Active |
| Estar-Z | ZHTD4022M | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS3S7010S | FDA UDI | Class II | Active |
| OneGuide Path Drill | OGSD2513T | FDA UDI | Class I | Active |
| US System | OAA600S | FDA UDI | Class II | Active |
| US/SS/GS System | GSTA6610NWH | FDA UDI | Class II | Active |
| Straight Fixture Surgical Tap | O2FTS50 | FDA UDI | Class I | Active |
| Twist Drill | 2D2218FNLC | FDA UDI | Class I | Active |
| US/SS/GS System | EGC100WH | FDA UDI | Class II | Active |
| Lance Drill | OSLD15 | FDA UDI | Class I | Active |
| Remover Screw | FRKCSE20SJ2 | FDA UDI | Class I | Active |
| GS System | GSCA4040 | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS2S4518S | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS3S4013S | FDA UDI | Class II | Active |
| OneGuide Implant Anchor | HOGFAW | FDA UDI | Class I | Active |
| Excellent Solid Abutment Driver | HESDSL | FDA UDI | Class I | Active |
| OssBuilder System | OBAC403018 | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAW735NTH | FDA UDI | Class II | Active |
| NoMount Driver | USNMDRL | FDA UDI | Class I | Active |
| Estar-Z | ZSTD4014T | FDA UDI | Class II | Active |
| Ts Fixture System | BTS3S4511S | FDA UDI | Class II | Active |
| 122 Taper Drill | H122TPD4506 | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | US17MAM4820TH | FDA UDI | Class II | Active |
| Plastic Scaler Connector | HICSCS2 | FDA UDI | Class I | Active |
| Estar-Z | ZP3C1014T | FDA UDI | Class II | Active |
| SS SA Fixture | ASS2R4010S28 | FDA UDI | Class II | Active |
| US System | MGS100 | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | MEW100TH | FDA UDI | Class II | Active |
| SS Solid Impression Cap | SSIP600 | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | SSSRC487 | FDA UDI | Class II | Active |
| OneGuide Taper Drill | OGTPD5507WC | FDA UDI | Class I | Active |
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