Class Class II
EK D3.3 and Ultra Wide Implants (K240232)
Description
EK D3.3 and Ultra Wide Implants by Hiossen, Inc., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240232
Clearance Date2024-09-13
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240232
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. EK D3.3 and Ultra Wide Implants (K240232) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022 |
| 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 |
Trace the full predicate network for K240232
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.