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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 16 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OSSTEM Implant System | BTS2S5013S | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS4S6008S | FDA UDI | Class II | Active |
| Taper Fixture Surgical Tap | OFTS35 | FDA UDI | Class I | Active |
| Estar-Z | ZTB2022T | FDA UDI | Class II | Active |
| OSSTEM Implant System | BTS3S7013S | FDA UDI | Class II | Active |
| OssBuilder System | OBAC501018 | FDA UDI | Class II | Active |
| 122 Taper Drill Non Stopper | 122NTPD6010 | FDA UDI | Class I | Active |
| OsstemGuide Twist Drill | QGTD3807 | FDA UDI | Class I | Active |
| Bone Compaction Drill | BCD5004 | FDA UDI | Class I | Active |
| Tissue Punch | HOGTP50WC | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS3S4513S | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAW625N | FDA UDI | Class II | Active |
| US Implant Transfer Impression Coping | ICPW601L | FDA UDI | Class I | Active |
| ET US SS Prosthetic system | AIHW603 | FDA UDI | Class II | Active |
| OSSTEM Implant System - Abutment | TSMA5040MP | FDA UDI | Class II | Active |
| OneGuide Taper Drill | HGTPD5506SWC | FDA UDI | Class I | Active |
| US SA Implant System | AUS3P5011S | FDA UDI | Class II | Active |
| 123 Twist Drill | 2D304607T | FDA UDI | Class I | Active |
| Estar-Z | ZTC1018T | FDA UDI | Class II | Active |
| Estar-Z | ZTA0020T | FDA UDI | Class II | Active |
| 123 Twist Drill | 3D556506T | FDA UDI | Class I | Active |
| Rigid Lab Analog | ETRLA4507 | FDA UDI | Class I | Active |
| Osstem Abutment System | TSPTA4060R | FDA UDI | Class II | Active |
| ET Prosthetic System | HGTFA4537MNW | FDA UDI | Class II | Active |
| ET/SS Implant System | HGFSA503SHW | FDA UDI | Class II | Active |
| ET/SS Implant System | HGAGA554SBW | FDA UDI | Class II | Active |
| ET Prosthetic System | HGRGA4527MP | FDA UDI | Class II | Active |
| SS System | SS2W1810 | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | AICM100 | FDA UDI | Class II | Active |
| Easy Screw Removal KIT | HKSFRK | FDA UDI | Class I | Active |
| OneGuide Taper Cortical Drill | HOGTCD4510 | FDA UDI | Class I | Active |
| SS SA Fixture | ASS3R4011S18 | FDA UDI | Class II | Active |
| SS System | SSCA604 | FDA UDI | Class II | Active |
| Bone Compaction Drill | BCD3505 | FDA UDI | Class I | Active |
| US/SS/GS System | GSRA5440P | FDA UDI | Class II | Active |
| 485 Drill | O485D4007 | FDA UDI | Class I | Active |
| Guide | HGZB01S | FDA UDI | Class I | Active |
| 485 Drill | O485D5508 | FDA UDI | Class I | Active |
| OneGuide Path Drill | OGSD2513WC | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTA2016M | FDA UDI | Class II | Active |
| Taper Cortical Drill | TCD4C35 | FDA UDI | Class I | Active |
| US/SS/GS System | CAR517 | FDA UDI | Class II | Active |
| OneGuide Taper Drill | OGTPD3518WC | FDA UDI | Class I | Active |
| Twist Drill | 2D2318FNLC | FDA UDI | Class I | Active |
| SS Excellent Solid Impression Coping | SSEIC607 | FDA UDI | Class I | Active |
| Osstem Abutment System | SSPTA4810R | FDA UDI | Class II | Active |
| SS Scan Body | SSNSBWL | FDA UDI | Class I | Active |
| Protect Screw | OOPISB2PR | FDA UDI | Class I | Active |
| 122 Taper Drill | 122TPD4010 | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTB3014T | FDA UDI | Class II | Active |
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