Class Class II
CeraRoot TL Implant System (TL) (K242072)
Description
CeraRoot TL Implant System (TL) by Ceraroot SL, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242072
Clearance Date2025-05-14
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242072
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. CeraRoot TL Implant System (TL) (K242072) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190406 | SDS2.2 dental implant | Sds Swiss Dental Solutions AG | 2020 |
| K180477 | Straumann PURE Ceramic Implant System | Institut Straumann AG | 2019 |
| K163043 | Zeramex P6 Dental Implant System | Dentalpoint AG | 2016 |
| K132881 | Z5C | Z-Systems AG | 2014 |
| K093595 | CERAROOT IMPLANT SYSTEM | Oral Iceberg S.L. | 2011 |
Trace the full predicate network for K242072
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.