Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) (K242064)
Description
Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) by Smart Denture Conversions, LLC, an FDA 510(k) cleared dental device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242064
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. Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) (K242064) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240208 | DESS Dental Smart Solutions | Terrats Medical SL | 2024 |
| K192614 | Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Ab... | Megagen Implant Co., Ltd. | 2020 |
| K161416 | Multi-unit Abutment Plus | Nobel Biocare AB | 2017 |
| K072570 | NOBELACTIVE MULTI UNIT ABUTMENT | Nobel Biocare AB | 2007 |
Trace the full predicate network for K242064
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.