Class Class II
ZENEX Implant System_Long (K240560)
Description
ZENEX Implant System_Long by Izenimplant Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240560
Clearance Date2024-10-30
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240560
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. ZENEX Implant System_Long (K240560) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221453 | S.I.N. Dental Implant System | S.I.N. Sistema DE Implante Nacion... | 2022 |
| K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | 2022 |
| K161604 | OSSTEM Implant System | Osstem Implant Co., Ltd. | 2016 |
Trace the full predicate network for K240560
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.