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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 10 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ET Rigid Outer Driver | HRD45S | FDA UDI | Class I | Active |
| US/SS/GS System | CAW635NTH | FDA UDI | Class II | Active |
| OneMS Path Drill | OMSD1513 | FDA UDI | Class I | Active |
| Machine Screw Driver | HAMSD09S | FDA UDI | Class I | Active |
| Three Cutter Twist Drill | H3D2718FNLC | FDA UDI | Class I | Active |
| US/SS/GS System | GSTA5650WH | FDA UDI | Class II | Active |
| TS Convertible Pick-up Guide Pin | GSCGP480L | FDA UDI | Class I | Active |
| OSSTEM Implant System | TSHA703R | FDA UDI | Class II | Active |
| US SA Implant System | US2R4515S | FDA UDI | Class II | Active |
| Twist Drill | HSMSD30S | FDA UDI | Class I | Active |
| OsstemGuide Drill Guide | QGDG46W | FDA UDI | Class I | Active |
| SS System | SSC605 | FDA UDI | Class II | Active |
| Screw Removal Drill | OSRD10L | FDA UDI | Class I | Active |
| TS Scan Healing Abutment Carrier | TSSHAC600 | FDA UDI | Class I | Active |
| Taper Drill | HTPD3C4506 | FDA UDI | Class I | Active |
| OssBuilder System | SMHI430USR | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAW735TH | FDA UDI | Class II | Active |
| SS SA Fixture | ASS3R4007S18 | FDA UDI | Class II | Active |
| NoMount Driver | TSNMDME | FDA UDI | Class I | Active |
| Estar-Z | ZP9D4030T | FDA UDI | Class II | Active |
| Trephine Drill | HTD52 | FDA UDI | Class I | Active |
| SS SA Fixture | SS2W5011S20 | FDA UDI | Class II | Active |
| Membrane Lifter | SNML3813TS | FDA UDI | Class I | Active |
| OSSTEM Implant System - Abutment | GSTA6620WH | FDA UDI | Class II | Active |
| Estar-Z | ZP9C1022T | FDA UDI | Class II | Active |
| Bone Spreader | OSNBS3015T | FDA UDI | Class I | Active |
| OneGuide US Implant Driver | HOGFDM50U | FDA UDI | Class I | Active |
| SS SA Fixture | SS3R4511S18 | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | SSCAP6036C | FDA UDI | Class II | Active |
| Estar-Z | ZSTC1018T | FDA UDI | Class II | Active |
| Taper Drill | HTPD3C7013 | FDA UDI | Class I | Active |
| OsstemGuide Twist Drill | QGTD3313 | FDA UDI | Class I | Active |
| Estar-Z | ZHTC1018M | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS4S5011S | FDA UDI | Class II | Active |
| US SA Implant System | AUS2W5010S | FDA UDI | Class II | Active |
| Orthodontic Screw Removal Tool | OSRT18E | FDA UDI | Class I | Active |
| OneGuide Taper Drill | HOGTPD3518WC | FDA UDI | Class I | Active |
| OneGuide Taper Drill | OGTPD4508S | FDA UDI | Class I | Active |
| Positioning Guide | APG203 | FDA UDI | Class I | Active |
| OSSTEM Implant System | BTS4S7008S | FDA UDI | Class II | Active |
| Taper Drill | HTPD3C7011 | FDA UDI | Class I | Active |
| HS/HG Prosthetic System | HSSPC4804R | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HUERA50204RW | FDA UDI | Class II | Active |
| US/SS/GS System | SSCA604NWH | FDA UDI | Class II | Active |
| ET/SS Implant System | ASS3R4513S28 | FDA UDI | Class II | Active |
| ET Prosthetic System | HGTFA4535MHW | FDA UDI | Class II | Active |
| Ts Fixture System | BTS2M3510S | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HSHNA601WOW | FDA UDI | Class II | Active |
| SS SA Fixture | ASS2R4008S28 | FDA UDI | Class II | Active |
| Taper Drill | HTPD3C5011 | FDA UDI | Class I | Active |
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