TiGEN Abutment, PMMA Abutment and Scan Healing Abutment (K234142)
Description
TiGEN Abutment, PMMA Abutment and Scan Healing Abutment by Megagen Implant Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K234142
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. TiGEN Abutment, PMMA Abutment and Scan Healing Abutment (K234142) cites 8 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw... | Nobel Biocare AB | 2024 |
| K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | Megagen Implant Co., Ltd. | 2022 |
| K220751 | Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA | Institut Straumann AG | 2022 |
| K203554 | AnyOne External Implant System | Megagen Implant Co., Ltd. | 2021 |
| K210161 | AnyOne Onestage Implant System | Megagen Implant Co., Ltd. | 2021 |
| K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 |
| K122192 | NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT... | Straumann USA, LLC | 2012 |
| K052369 | EXFEEL IMPLANT SYSTEM | Megagen Co., Ltd. | 2006 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241616 | ALLONUS Tech Prosthetics | Allonus Tech Co., Ltd. | 2024 |
Trace the full predicate network for K234142
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.