# K093595: Ceraroot Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Oral Iceberg S.L.
- Decided: Jan 4, 2011 after 411 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: 2 generations back to K022562 (2002). 4 ancestors in all.
27 later devices descend from it; 5 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061971: Zirconia Implant, Nobel Biocare AB (2007) Summary page 2.
- K062542: Z-LOOK3 Dental Implant System, Model Z3-XXX, Z-Systems AG (2007) Summary page 2.

## Most influential descendants
- K120793: Z-LOOK3 Evo SLM (2012), 19 descendants of its own
- K151328: PURE Ceramic Implants (2016), 12 descendants of its own
- K171769: Straumann PURE Ceramic Implants (2017), 8 descendants of its own
- K132881: Z5C (2014), 8 descendants of its own
- K180477: Straumann PURE Ceramic Implant System (2019), 6 descendants of its own

## Indications for use
CeraRoot 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 dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot implants can be placed in immediate or delayed tooth extractions. CeraRoot implants are not intended for immediate loading. The CeraRoot dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.

Source page: https://510kreport.com/device/K093595
Methodology: https://510kreport.com/methodology