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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 230 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| One485 Pilot Drill | O4D3506WC | FDA UDI | Class I | Active |
| One485 Twist Drill | O4D2207WC | FDA UDI | Class I | Active |
| Long Shank Countersink | ACD500C | FDA UDI | Class I | Active |
| Posterior Guide | D4UPG30 | EUDAMEDFDA UDI | Class I | Active |
| One485 Drill | HO4D4507 | FDA UDI | Class I | Active |
| SS SA Fixture System | ASS3W5010S20 | FDA UDI | Class II | Active |
| One485 Drill | O4D4506 | FDA UDI | Class I | Active |
| SS Excellent Solid Burn-out Cylinder | SSEP480S | FDA UDI | Class I | Active |
| One485 Twist Drill | O4D2204WC | FDA UDI | Class I | Active |
| TS BA Fixture System | TS3M3508B | FDA UDI | Class II | Active |
| TS BA Fixture System | TS3S4508B | FDA UDI | Class II | Active |
| OneGuide Drill Handle | OGDH | FDA UDI | Class I | Active |
| 123 Drill Stop | HODST06 | EUDAMEDFDA UDI | Class I | Active |
| SS SA Fixture System | SS3R4508S28 | FDA UDI | Class II | Active |
| OneGuide KS NoMount Driver | OGNMDR57K | EUDAMEDFDA UDI | Class I | Active |
| KS Remover Screw | HKSFRSR40F | EUDAMEDFDA UDI | Class I | Active |
| Perforation Drill | ORPED2007 | FDA UDI | Class I | Active |
| OneMS TS Implant Driver (Stopper Type) | OGFDSM35 | EUDAMEDFDA UDI | Class I | Active |
| SS SA Fixture System | ASS2W5007S20 | FDA UDI | Class II | Active |
| SS SA Fixture System | SS3R3508S28 | FDA UDI | Class II | Active |
| Bone Compaction Drill | BCD5005 | FDA UDI | Class I | Active |
| Gracey Curette | HICC0102 | FDA UDI | Class I | Active |
| Perforation Drill | HORPUD2003 | FDA UDI | Class I | Active |
| Y-Connector | OSNYCT | FDA UDI | Class I | Active |
| US Fixture Lab Analog | RFAW300 | FDA UDI | Class I | Active |
| Bone Compaction Drill | HBCD4003 | FDA UDI | Class I | Active |
| Rigid Lab Analog | HGRLA5005S | FDA UDI | Class I | Active |
| 123 Drill Stop | ODS08 | FDA UDI | Class I | Active |
| Gracey Curette | HICC1314 | FDA UDI | Class I | Active |
| OneGuide TS Implant Anchor | OGFAW | FDA UDI | Class I | Active |
| Bone Compaction Drill | BCDI06 | FDA UDI | Class I | Active |
| OsstemGuide Initial Drill | QGID20R | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | 122NTPD4508 | FDA UDI | Class I | Active |
| Rigid Lab Analog | HGRLA6005S | FDA UDI | Class I | Active |
| Direct Drill | UTTD3C6213L | FDA UDI | Class I | Active |
| Saw Protector | OSP130 | EUDAMEDFDA UDI | Class I | Active |
| 123 Cortical Drill | O2CD50 | FDA UDI | Class I | Active |
| Rigid Lab Analog | HGRLA4504 | FDA UDI | Class I | Active |
| Bone Compaction Drill | HBCD4006 | FDA UDI | Class I | Active |
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