HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) (K241003)
Description
HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) by Hiossen, Inc., an FDA 510(k) cleared dental device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241003
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. HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) (K241003) cites 7 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221972 | Warantec Custom Abutment | Warantec Co., Ltd. | 2023 |
| K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022 |
| K183242 | ET IV SA Dental Implants | Hiossen, Inc. | 2019 |
| K153332 | ETIII SA Fixture System (O3.2mm) | Hiossen, Inc. | 2016 |
| K151626 | ET III Bio-SA Fixture System | Hiossen, Inc. | 2016 |
| K140934 | HIOSSEN IMPLANT SYSTEM | Hiossen, Inc. | 2014 |
| K123627 | ET SMARTFIT ABUTMENT | Hiossen, Inc. | 2013 |
Trace the full predicate network for K241003
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.