Class Class II
JDZygoma dental implants (K240143)
Description
JDZygoma dental implants by Jdentalcare Srl, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240143
Clearance Date2024-10-11
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240143
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. JDZygoma dental implants (K240143) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210356 | Noris Medical Dental Implants System | Noris Medical , Ltd. | 2022 |
| K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical , Ltd. | 2016 |
| K152093 | NobelZygoma 45° | Nobel Biocare AB | 2016 |
| K052885 | ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 1... | Nobel Biocare USA, LLC | 2005 |
Trace the full predicate network for K240143
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.