Class Class II
PreXolid CAD/CAM abutments (K240725)
Description
PreXolid CAD/CAM abutments by Eclectic Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240725
Clearance Date2024-10-18
Clearance TypeTraditional
Product CodeNHA
Regulation Number872.3630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240725
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. PreXolid CAD/CAM abutments (K240725) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | Megagen Implant Co., Ltd. | 2022 |
| K122231 | XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM | Megagen Implant Co., Ltd. | 2012 |
Trace the full predicate network for K240725
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.