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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 229 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CT Checker | CTCHK57S | EUDAMEDFDA UDI | Class I | Active |
| SmartGuide Twist Drill | SGTD2207S | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | H122NTPD4508 | FDA UDI | Class I | Active |
| Fixture Lab Analog | HGFLAM | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | 122NTPD5007 | FDA UDI | Class I | Active |
| Bone Compaction Drill | BCD50055 | FDA UDI | Class I | Active |
| TS BA Fixture System | TS3S5011B | FDA UDI | Class II | Active |
| Straight Fixture Surgical Tap | O2FTS40 | FDA UDI | Class I | Active |
| Bone Compaction Drill | BCDI07 | FDA UDI | Class I | Active |
| Reamer Tip | FRTS480 | EUDAMEDFDA UDI | Class I | Active |
| OneGuide Fixture Driver (Stopper Type) | OGFDSR57 | FDA UDI | Class I | Active |
| Ridge Split Chisel | HRSS25 | FDA UDI | Class I | Active |
| OsstemGuide Removal Tool | QGRTR | FDA UDI | Class I | Active |
| One485 Drill | O4D4008 | FDA UDI | Class I | Active |
| Metal Curette | HICPM | FDA UDI | Class I | Active |
| US Implant Lab Analog | FAR300 | FDA UDI | Class I | Active |
| Bone Compaction Drill | HBCD3506 | FDA UDI | Class I | Active |
| SmartBrush2 | OOPISB26S | FDA UDI | Class I | Active |
| Perforation Drill | HRPMD1507 | FDA UDI | Class I | Active |
| Multi Angled Abutment system | HGMAA417MHW | FDA UDI | Class II | Active |
| SS SA Fixture System | SS3W5010S20 | FDA UDI | Class II | Active |
| Orthodontic Screw System | OSSH1408 | FDA UDI | Class II | Active |
| SS SA Fixture System | ASS2R4507S18 | FDA UDI | Class II | Active |
| Osstem Mixing Tip | OMTH100 | FDA UDI | Class I | Active |
| Ridge Split Chisel | ORSS15 | FDA UDI | Class I | Active |
| OneGuide Bone Profiler | HOGBPSWC | FDA UDI | Class I | Active |
| OneGuide US NoMount Driver | HOGNMDM50U | EUDAMEDFDA UDI | Class I | Active |
| TS Rigid Lab Analog | GSRLA460 | FDA UDI | Class I | Active |
| Long Shank Countersink | ACD375C | FDA UDI | Class I | Active |
| TS BA Fixture System | TS3S4008B | FDA UDI | Class II | Active |
| OneGuide KS NoMount Driver | HOGNMDM50K | FDA UDI | Class I | Active |
| OneGuide TS NoMount Driver | HOGNMDM57 | EUDAMEDFDA UDI | Class I | Active |
| Direct Drill | H3D6213FNLC | FDA UDI | Class I | Active |
| US Esthetic-low Lab Analog | MERW300 | FDA UDI | Class I | Active |
| Bone Compaction Drill | HBCDI07 | FDA UDI | Class I | Active |
| TS BA Fixture System | BTS3M3513B | FDA UDI | Class II | Active |
| TS Rigid Lab Analog | GSRLA471 | FDA UDI | Class I | Active |
| Bone Compaction Drill | BCD4005 | FDA UDI | Class I | Active |
| SS SA Fixture System | ASS2R4007S28 | FDA UDI | Class II | Active |
| One485 Pilot Drill | HO4D3506WC | FDA UDI | Class I | Active |
| Reamer Tip | GSRFRT600 | FDA UDI | Class I | Active |
| Stainless Steel Bowl | ARKB | FDA UDI | Class I | Active |
| Expanding Osteotome | OST20EA | FDA UDI | Class I | Active |
| SS SA Fixture System | ASS3W5008S20 | FDA UDI | Class II | Active |
| Orthodontic Screw Removal Tool | OSRT18H | EUDAMEDFDA UDI | Class I | Active |
| SS Digital Lab Analog | SSDLA480B | FDA UDI | Class I | Active |
| Efr Kit | HSFRK | FDA UDI | Class I | Active |
| MS Lab Analog Provisional | MSTLA | FDA UDI | Class I | Active |
| Concave Osteotome | OST20CA | FDA UDI | Class I | Active |
| One485 Drill | O4D4007 | FDA UDI | Class I | Active |
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