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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 9 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ET/SS Implant System | SS3R3511S18 | FDA UDI | Class II | Active |
| OssBuilder System | OBAC532020 | FDA UDI | Class II | Active |
| Estar-Z | ZTA0012T | FDA UDI | Class II | Active |
| US/SS/GS System | GSTA5611WH | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS3S4013S | FDA UDI | Class II | Active |
| OneGuide Taper Cortical Drill | HOGTCD5007WC | FDA UDI | Class I | Active |
| US SA Implant System | AUS3W5015S | FDA UDI | Class II | Active |
| Single Guide Pin | PGSP22 | FDA UDI | Class I | Active |
| SS SA Fixture | SS2W4510S20 | FDA UDI | Class II | Active |
| 122 Taper Drill Non Stopper | 122NTPD4005 | FDA UDI | Class I | Active |
| ET/SS Implant System | ASS3R4508S18 | FDA UDI | Class II | Active |
| SMARTbuilder System | SMHA553R | FDA UDI | Class II | Active |
| Osstem Abutment System | USPTA4040R | FDA UDI | Class II | Active |
| Bone Profiler | GSBP45 | FDA UDI | Class I | Active |
| US SA Implant System | AUS3R4010S | FDA UDI | Class II | Active |
| SS SA Fixture | ASS2R4015S18 | FDA UDI | Class II | Active |
| OneGuide Reamer | HOGRD58 | FDA UDI | Class I | Active |
| Bone Carrier Head | HOCBCH37W | FDA UDI | Class I | Active |
| Machine Screw Driver | AMSD12S | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTB1025T | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS3S4513S | FDA UDI | Class II | Active |
| 122 Taper Drill Non Stopper | H122NTPD4506 | FDA UDI | Class I | Active |
| SMARTbuilder System (SB1) | SB1P125A | FDA UDI | Class II | Active |
| US/SS/GS System | CAW634N | FDA UDI | Class II | Active |
| Estar-ZE | ZEHTC3012T | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS3S5010S | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS2M3510S | FDA UDI | Class II | Active |
| Estar-Z | ZHTD3022M | FDA UDI | Class II | Active |
| Solid Abutment Driver | SDRL | FDA UDI | Class I | Active |
| HS/HG Prosthetic System | HSEPC4804R | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HUCMA70105WHW | FDA UDI | Class II | Active |
| 122 Taper Drill Non Stopper | H122NTPD4515 | FDA UDI | Class I | Active |
| MS Lab Analog Narrow Ridge | MSPLA | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | CAW537TH | FDA UDI | Class II | Active |
| SS SA Fixture System | ASS2W4507S20 | FDA UDI | Class II | Active |
| Estar-Z | ZTB3012T | FDA UDI | Class II | Active |
| OssBuilder System | OBAC503018 | FDA UDI | Class II | Active |
| HySil Impression Materials | ESS50EL | FDA UDI | Class II | Active |
| Estar-Z | ZHTD4010T | FDA UDI | Class II | Active |
| Estar-Z | ZTC2010T | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS3M3008S | FDA UDI | Class II | Active |
| Guide | OGSB02L | FDA UDI | Class I | Active |
| Osstem Abutment System | USPTA3570M | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | TSQTA4550RNTH | FDA UDI | Class II | Active |
| US SA Implant System | AUS2R4508S | FDA UDI | Class II | Active |
| Ridge Split Chisel | ORSO30 | FDA UDI | Class I | Active |
| US System | OAA200S | FDA UDI | Class II | Active |
| ET/SS Implant System | SS2R4508S18 | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HUSFA60104WT | FDA UDI | Class II | Active |
| US/SS/GS System | TERAW627C | FDA UDI | Class II | Active |
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