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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 25 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| US System | OAA300S | FDA UDI | Class II | Active |
| OssBuilder System | OBAC432020A | FDA UDI | Class II | Active |
| US SA Implant System | US3P5013S | FDA UDI | Class II | Active |
| Countersink | USTCS45W | FDA UDI | Class I | Active |
| HU/HS/HG Prosthetic System | HGCPL6010SW | FDA UDI | Class II | Active |
| US/SS/GS System | SSGCN480WH | FDA UDI | Class II | Active |
| T1-C | T1-C | FDA UDI | Class II | Active |
| OssBuilder System | SM3W12129SB | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAR615TH | FDA UDI | Class II | Active |
| US/SS/GS System | ERAW635CTH | FDA UDI | Class II | Active |
| US SA Implant System | US2R4007S | FDA UDI | Class II | Active |
| Estar-Z | ZTA3518T | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSRA4711P | FDA UDI | Class II | Active |
| US SA Implant System | AUS3W5013S | FDA UDI | Class II | Active |
| OneGuide Accessory KIT | HOGAK | FDA UDI | Class I | Active |
| TS Implant System | HGQTA455MNT | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HGTFA50505SNW | FDA UDI | Class II | Active |
| ET/SS Implant System | SS2W5010S20 | FDA UDI | Class II | Active |
| Reamer Tip | GSRFRT400 | FDA UDI | Class I | Active |
| OSSTEM Implant System | BTS2S4013S | FDA UDI | Class II | Active |
| OneMS Drill | HOMD2711 | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS2S5010S | FDA UDI | Class II | Active |
| Estar-Z | ZTB3025T | FDA UDI | Class II | Active |
| US SA Implant System | AUS2M3510S | FDA UDI | Class II | Active |
| OssBuilder System | OBAC532520 | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | NMTW200 | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS4S5011S | FDA UDI | Class II | Active |
| OneGuide Taper Drill | OGTPD5018WC | FDA UDI | Class I | Active |
| ET Prosthetic System | HGTFA5014SHW | FDA UDI | Class II | Active |
| HySil Plus Impression Materials | ESS50LSB | FDA UDI | Class II | Active |
| US Esthetic-low Impression Coping | MSW200 | FDA UDI | Class I | Active |
| US/SS/GS System | CAR635TH | FDA UDI | Class II | Active |
| SS SA Fixture | ASS2R4010S28 | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS3S4007S | FDA UDI | Class II | Active |
| Long Shank Pilot Drill | HAPD270C | FDA UDI | Class I | Active |
| OSSTEM Implant System | BTS2S4007S | FDA UDI | Class II | Active |
| Trephine Drill | HTD42 | FDA UDI | Class I | Active |
| 123 Twist Drill | 2D304110T | FDA UDI | Class I | Active |
| US/SS/GS System | MEPW100TH | FDA UDI | Class II | Active |
| ET Prosthetic System | HGTFA6035SHW | FDA UDI | Class II | Active |
| US/SS/GS System | CAR515NTH | FDA UDI | Class II | Active |
| Plastic Scaler Connector | HICSCE | FDA UDI | Class I | Active |
| Taper Ultra KIT | HULTPK | FDA UDI | Class I | Active |
| HU/HS/HG Prosthetic System | HGTFA50304SHW | FDA UDI | Class II | Active |
| US/SS/GS System | GSRA5420P | FDA UDI | Class II | Active |
| Estar-Z | ZHTA1016M | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | SSCAP6046CN | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS4S5015S | FDA UDI | Class II | Active |
| Bone Profiler | GSBP50 | FDA UDI | Class I | Active |
| Remover Screw | HFRSMNR35 | FDA UDI | Class I | Active |
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