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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 227 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OSSTEM Implant System | BTS3M3513S | FDA UDI | Class II | Active |
| Single Guide Pin | PGSP22 | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | TCAW627N | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | MEW200TH | FDA UDI | Class II | Active |
| TS BA Fixture System | BTS3M3510B | FDA UDI | Class II | Active |
| TS Rigid Reamer Tip | GSRFRT450 | FDA UDI | Class I | Active |
| SS NoMount Torque Driver | SSNMT39L | EUDAMEDFDA UDI | Class I | Active |
| Bone Compaction Drill | HBCD3510 | FDA UDI | Class I | Active |
| Taper Drill | HTPD3C6008 | FDA UDI | Class I | Active |
| OSSTEM Implant System | BTS4S5007S | FDA UDI | Class II | Active |
| Taper Drill | HTPD3C7006 | FDA UDI | Class I | Active |
| Estar-Z | ZHTC1020T | FDA UDI | Class II | Active |
| Estar-Z | ZTA3525T | FDA UDI | Class II | Active |
| SS SA Fixture System | ASS3W6013S20 | FDA UDI | Class II | Active |
| Ts Fixture System | TS2S4010S | FDA UDI | Class II | Active |
| ET Prosthetic System | HGRGA4524SP | FDA UDI | Class II | Active |
| Prosthetic System | HGSAD353S | FDA UDI | Class II | Active |
| HS/HG Prosthetic System | HSCTA482ROT | FDA UDI | Class II | Active |
| OneGuide Bone Anchor | OGBAR | EUDAMEDFDA UDI | Class I | Active |
| 123 Cortical Drill | 3CD35 | FDA UDI | Class I | Active |
| OneMS Lance Drill | OMLD1513 | FDA UDI | Class I | Active |
| TS Multi Digital Lab Analog | TSMDLAB | FDA UDI | Class I | Active |
| Perforation Drill | HRPED1507 | FDA UDI | Class I | Active |
| KS NoMount Driver | KSNMDCRE | EUDAMEDFDA UDI | Class I | Active |
| ET Rigid Impression Coping | ETRIC4507S | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | H122NTPD4008 | FDA UDI | Class I | Active |
| Hiossen Simple Instrument KIT | HDCHOKIT | FDA UDI | Class I | Active |
| Metal Scaler | OICSMS | FDA UDI | Class I | Active |
| Straight Fixture Surgical Tap | H2FTS40 | FDA UDI | Class I | Active |
| SS SA Fixture System | SS2R4010S18 | FDA UDI | Class II | Active |
| Sa Mount | USUM10 | FDA UDI | Class I | Active |
| Bone Compaction Drill | BCD3510 | FDA UDI | Class I | Active |
| TS BA Fixture System | TS3S4007B | FDA UDI | Class II | Active |
| Bone Compaction Drill | BCDI10 | FDA UDI | Class I | Active |
| Rigid Burn-out Cylinder | HGRBC60SB | FDA UDI | Class I | Active |
| OsstemGuide TS Mount | QGHGMW | EUDAMEDFDA UDI | Class I | Active |
| Bone Compaction Drill | BCD4508 | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | 122NTPD4510 | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | 122NTPD5008 | FDA UDI | Class I | Active |
| TS BA Fixture System | BTS3S4507B | FDA UDI | Class II | Active |
| EK Cortical Drill 3 | HCD4C30K | FDA UDI | Class I | Active |
| Concave Osteotome | HOST20CA | FDA UDI | Class I | Active |
| Bone Compaction Drill | HBCD4004 | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | 122NTPD4513 | FDA UDI | Class I | Active |
| Smart Template Free-end Bridge Large, Short | HSGTFB90LS | FDA UDI | Class I | Active |
| 122 Taper Drill Non Stopper | H122NTPD4504 | FDA UDI | Class I | Active |
| OneGuide Training KIT | OGTRKIT | FDA UDI | Class I | Active |
| Rigid Lab Analog | HGRLA7005S | FDA UDI | Class I | Active |
| Guide Screw | GSBGM | EUDAMEDFDA UDI | Class I | Active |
| Bite Impression Coping Driver | OICDM | EUDAMEDFDA UDI | Class I | Active |
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