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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 228 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Plastic Scaler Tip | OPSTP | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | H122NTPD5004 | FDA UDI | Class I | Active |
| US NoMount Driver | USNMD51WS | FDA UDI | Class I | Active |
| SS Solid Impression Cap | SSIP480 | FDA UDI | Class I | Active |
| Parallel Pin for HM | HMSPPN | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | H122NTPD5015 | FDA UDI | Class I | Active |
| MS Lab Analog Narrow Ridge | MSPLA | FDA UDI | Class I | Active |
| 123 Cortical Drill | 3CD50 | FDA UDI | Class I | Active |
| SS Solid Shoulder Analog Pin | SSSAP480 | FDA UDI | Class I | Active |
| Multi Angled Abutment system | HGMAA530MHW | FDA UDI | Class II | Active |
| Ts Snap On Mount | GSSMS | FDA UDI | Class I | Active |
| MS Removal Tool | OMRT25E | FDA UDI | Class I | Active |
| OneArch KIT | HOARK | FDA UDI | Class I | Active |
| Cover Cap Driver Ejector SET Short | SMCDESS | EUDAMEDFDA UDI | Class I | Active |
| KS Remover Screw | KSFRSM35 | FDA UDI | Class I | Active |
| Bone Compaction Drill | HBCD4507 | FDA UDI | Class I | Active |
| SS SA Fixture System | SS2R4508S28 | FDA UDI | Class II | Active |
| SS Solid Burn-out Cylinder | SSSP600S | FDA UDI | Class I | Active |
| Bone Compaction Drill | BCD4006 | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | 122NTPD5011 | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | 122NTPD5005 | FDA UDI | Class I | Active |
| Shaping Drill | TFCD600 | FDA UDI | Class I | Active |
| Bone Compaction Drill | BCD5006 | FDA UDI | Class I | Active |
| OneGuide TS Implant Driver | HOGIDHSR57 | EUDAMEDFDA UDI | Class I | Active |
| TS BA Fixture System | TS3M3511B | FDA UDI | Class II | Active |
| One485 Drill (F4.5 Hard) | O4HD5007WC | FDA UDI | Class I | Active |
| OneGuide TS Implant Driver (Stopper Type) | OGFDSR57 | EUDAMEDFDA UDI | Class I | Active |
| Rigid Burn-out Cylinder | ETRBC45S | FDA UDI | Class I | Active |
| Bone Compaction Drill | HBCD5010 | FDA UDI | Class I | Active |
| SmartGuide Twist Drill | SGTD2207S | FDA UDI | Class I | Active |
| Bone Compaction Drill | HBCD4003 | FDA UDI | Class I | Active |
| US Implant Driver | USMFDL | EUDAMEDFDA UDI | Class I | Active |
| Smartbrush 2 | OPISB23L | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | 122NTPD3504 | FDA UDI | Class I | Active |
| BP Guide Distance Setup Pin | PGDSP | FDA UDI | Class I | Active |
| One485 Drill (F4.5 Hard) | O4HD5008WC | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | 122NTPD4008 | FDA UDI | Class I | Active |
| Direct Drill | 3D5213FNLC | FDA UDI | Class I | Active |
| SS SA Fixture System | ASS2W5011S20 | FDA UDI | Class II | Active |
| Bone Compaction Drill | BCD4007 | FDA UDI | Class I | Active |
| Bone Compaction Drill | HBCDI07 | FDA UDI | Class I | Active |
| Plastic Scaler Connector | OICSCE2 | FDA UDI | Class I | Active |
| SS ComOcta Lab Analog | SSCLA605 | FDA UDI | Class I | Active |
| 123 Cortical Drill | O3CD40 | FDA UDI | Class I | Active |
| OneGuide Bone Profiler | OGBPSWC | FDA UDI | Class I | Active |
| TS BA Fixture System | TS3S4013B | FDA UDI | Class II | Active |
| Guide Screw | HKSBGM | FDA UDI | Class I | Active |
| Plastic Scaler Connector | HICSCK | FDA UDI | Class I | Active |
| Bone Compaction Drill | BCD4510 | FDA UDI | Class I | Active |
| SS SolidLab Analog | SSSA487 | FDA UDI | Class I | Active |
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