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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 32 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SS Scan Body | SSNSBWS | FDA UDI | Class I | Active |
| Ts Fixture System | BTS2M3513S | FDA UDI | Class II | Active |
| ET/SS Implant System | SS2R4013S18 | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HGTFA60307SHW | FDA UDI | Class II | Active |
| US/SS/GS System | ERAR545CWH | FDA UDI | Class II | Active |
| HS/HG Prosthetic System | HGABSST | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | SSCAP6036CNTH | FDA UDI | Class II | Active |
| SS Excellent Solid Lab Analog | SSEA605 | FDA UDI | Class I | Active |
| Taper Drill | HTPD3C4010 | FDA UDI | Class I | Active |
| SS SA Fixture System | SS2R4508S18 | FDA UDI | Class II | Active |
| Estar-Z | ZP3B4014T | FDA UDI | Class II | Active |
| Orthodontic Screw Removal Tool | HSRT12E | FDA UDI | Class I | Active |
| Three Cutter Twist Drill | H3D4611LC01 | FDA UDI | Class I | Active |
| OssBuilder System | SBAC4010TSR | FDA UDI | Class II | Active |
| 122 Taper Drill | H122TPD6008 | FDA UDI | Class I | Active |
| Orthodontic Screw Machine Driver | HSSMDB | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTA4025M | FDA UDI | Class II | Active |
| ET/SS Implant System | GSGC400NWH | FDA UDI | Class II | Active |
| TS Convertible Pick-up Guide Pin | GSCGP400L | FDA UDI | Class I | Active |
| Removal Tool for Fixture Mount | ERFW | FDA UDI | Class I | Active |
| ET Prosthetic System | HGTFA5024SNW | FDA UDI | Class II | Active |
| Tissue punch | OGTP35R | FDA UDI | Class I | Active |
| Bone Profiler | KSBP40 | FDA UDI | Class I | Active |
| OSSTEM Implant System | TS2S4011S | FDA UDI | Class II | Active |
| SmartGuide Twist Drill Short | HSGTD2207S | FDA UDI | Class I | Active |
| Estar-ZE | ZEHTA3525T | FDA UDI | Class II | Active |
| US system | SFAW625SC | FDA UDI | Class II | Active |
| One485 KIT | HKO485K | FDA UDI | Class I | Active |
| TS BA Fixture System | BTS3S4513B | FDA UDI | Class II | Active |
| OSSTEM Implant System | TS2S4511S | FDA UDI | Class II | Active |
| Perforation Drill | ORPMD2007 | FDA UDI | Class I | Active |
| TS Implant Pick-up Impression Coping | GSPIS7011N | FDA UDI | Class I | Active |
| OSSTEM Implant System - Abutment | GSTA5640WH | FDA UDI | Class II | Active |
| Trial Pin | UWFTP65 | FDA UDI | Class I | Active |
| Osstem Abutment System | GSAA4540NWH | FDA UDI | Class II | Active |
| Estar-ZE | ZEHTA3530M | FDA UDI | Class II | Active |
| SS Excellent Solid Lab Analog | SSEA607 | FDA UDI | Class I | Active |
| MS SA Implant System | MSD2508S40 | FDA UDI | Class II | Active |
| ET Prosthetic System | HGRGA5024SP | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HUAGA4042MHW | FDA UDI | Class II | Active |
| Estar-Z | ZHTC2025M | FDA UDI | Class II | Active |
| OssBuilder System | SM2W10127SB | FDA UDI | Class II | Active |
| OssBuilder System | SBAC3530TSM | FDA UDI | Class II | Active |
| HU/HS/HG Prosthetic System | HUERA60205WW | FDA UDI | Class II | Active |
| US/SS/GS System | ERAW634CWH | FDA UDI | Class II | Active |
| ET US SS Prosthetic system | CAW715NTH | FDA UDI | Class II | Active |
| US SA Implant System | AUS3P5010S | FDA UDI | Class II | Active |
| Taper Drill | TPTD3C3511T | FDA UDI | Class I | Active |
| 123 Drill Stop | ODS07 | FDA UDI | Class I | Active |
| 122 Taper Drill | H122TPD3510 | FDA UDI | Class I | Active |
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