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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 8 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Osstem Abutment System | USPTA5070W | FDA UDI | Class II | Active |
| Fixture Transfer Impression Coping | HGFTI4011MH | FDA UDI | Class I | Active |
| US Fixture Pick-up Impression Coping | ICSW600 | FDA UDI | Class I | Active |
| US/SS/GS System | CAR535 | FDA UDI | Class II | Active |
| GS System | GSAA4340N | FDA UDI | Class II | Active |
| Np-Cast Abutment System | HSCNA48RNT | FDA UDI | Class II | Active |
| US/SS/GS System | SSS484P | FDA UDI | Class II | Active |
| Osstem Abutment System | GSTTA4030NTH | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | GSTAS4741WH | FDA UDI | Class II | Active |
| Twist Drill | OSMSD20L | FDA UDI | Class I | Active |
| OneGuide Taper Drill | OGTPD4507W | FDA UDI | Class I | Active |
| Three Cutter Twist Drill | 3D3822T | FDA UDI | Class I | Active |
| Angled Torque Driver SET | HATD12S3S | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTA4016T | FDA UDI | Class II | Active |
| Estar-ZE | ZEHTA4012M | FDA UDI | Class II | Active |
| OneCAS Drill | HOCD3610 | FDA UDI | Class I | Active |
| TS Rigid Lab Analog | GSRLA760 | FDA UDI | Class I | Active |
| Solid Driver | HTS48L | FDA UDI | Class I | Active |
| HU/HS/HG Prosthetic System | HUUGA5512WNW | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HSSDA4805RP | FDA UDI | Class II | Active |
| Crest Remover | OCERM70A | FDA UDI | Class I | Active |
| Twist Drill | 2D2018FNLC | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS4S6011S | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | TSQTA4050MN | FDA UDI | Class II | Active |
| SS SA Fixture | SS2R4008S28 | FDA UDI | Class II | Active |
| Guide | OGSTRL | FDA UDI | Class I | Active |
| Estar-Z | ZP3A4016T | FDA UDI | Class II | Active |
| Drill Extension | HDERC | FDA UDI | Class I | Active |
| Bone Compaction Drill | BCD4513 | FDA UDI | Class I | Active |
| OSSTEM Implant System | BTS4S6010S | FDA UDI | Class II | Active |
| GS System | GSCTC600 | FDA UDI | Class II | Active |
| HySil Impression Materials | ESS50MB | FDA UDI | Class II | Active |
| US Implant Pick-up Impression Coping | ICFR500 | FDA UDI | Class I | Active |
| 122 Taper Drill | 122TPD5008 | FDA UDI | Class I | Active |
| Bone Spreader | OBSO28F | FDA UDI | Class I | Active |
| Machine Screw Driver | EIHD20 | FDA UDI | Class I | Active |
| HU/HS/HG Prosthetic System | HGTPA401MHW | FDA UDI | Class II | Active |
| US System | BFR413 | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | SSE487 | FDA UDI | Class II | Active |
| TSIII BA Fixture | BTS3S4013B | FDA UDI | Class II | Active |
| ET/SS Implant System | GSCA4030P | FDA UDI | Class II | Active |
| Bone Compaction Drill | BCD4003 | FDA UDI | Class I | Active |
| ET/SS Implant System | ASS2W4513S20 | FDA UDI | Class II | Active |
| SS SA Fixture System | SS3W5007S20 | FDA UDI | Class II | Active |
| TS BA Fixture System | BTS3S5007B | FDA UDI | Class II | Active |
| Estar-Z | ZP9C2016T | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | AIHR602 | FDA UDI | Class II | Active |
| Osstem Abutment System | GSST3520M | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | MEM300 | FDA UDI | Class II | Active |
| TSIII BA Fixture | TS3M3513B | FDA UDI | Class II | Active |
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