# K242072: CeraRoot TL Implant System (TL)

- Pathway: 510(k) (Traditional)
- Applicant: Ceraroot SL
- Decided: May 14, 2025 after 302 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K022562 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093595: Ceraroot Implant System, Oral Iceberg S.L. (2011) Summary page 5.

## Indications for use
CeraRoot TL dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot TL dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot TL implants can be placed in immediate or delayed tooth extractions. CeraRoot TL implants are intended for delayed loading. The CeraRoot TL dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies. The CeraRoot TL implants are the two-piece tissue level variant of the original CeraRoot implant system (one-piece). CeraRoot TL abutments are industrially manufactured prosthetic components made out from the same material as the implant.

Source page: https://510kreport.com/device/K242072
Methodology: https://510kreport.com/methodology