Class Class II
Highness Implant System (K240383)
Description
Highness Implant System by Highness Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240383
Clearance Date2024-10-31
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240383
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. Highness Implant System (K240383) cites 6 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203808 | Multi-unit Abutment, Multi-unit Angled Abutment | Megagen Implant Co., Ltd. | 2021 |
| K192347 | ST Internal Implant System | Megagen Implant Co., Ltd. | 2019 |
| K182448 | AnyRidge Octa 1 Implant System | Megagen Implant Co., Ltd. | 2019 |
| K160519 | Link Abutment for CEREC | Osstem Implant Co., Ltd. | 2016 |
| K123988 | ANYONETM INTERNAL IMPLANT SYSTEM | Megagen Implant Co., Ltd. | 2013 |
| K110955 | ANYRIDGE INTERNAL IMPLANT SYSTEM | Megagen Co., Ltd. | 2011 |
Trace the full predicate network for K240383
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.