# K132881: Z5C

- Pathway: 510(k) (Traditional)
- Applicant: Z-Systems AG
- Decided: Jul 3, 2014 after 293 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: 10 generations back to K944964 (1995). 85 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120793: Z-LOOK3 Evo SLM, Z-Systems AG (2012) Summary page 2.
- K041661: Nobel Biocare Endosseous Implants, Nobel Biocare Uas, Inc. (2004) Summary page 2.
- K091904: Nobelprocera ZI Abutment, Nobel Biocare AB (2009) Summary page 2.
- K091920: Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace Implants, Atlantis Gemini + Abutment for Nobel, Astra Tech, Inc. (2009) Summary page 2.
- K062277: Atlantis Abutment in Zirconia for Nobel Biocare Replace, Atlantis Components, Inc. (2006) Summary page 2.
- K083496: Camlog Implant System Modified Implants and Abutments, Altatec GmbH (2009) Summary page 2.
- K110640: Atlantis Abutment for Camlog Implant, Duplicate Abutment, Later Abutment, Astra Tech, Inc. (2011) Summary page 2.

## Most influential descendants
- K172668: W Zirconia Implants (2018), 4 descendants of its own
- K190243: Z5-BL (2020), 2 descendants of its own
- K181953: SDS1.2 dental implant (2019), 1 descendant of its own
- K192053: W Zirconia Implants (2019), 1 descendant of its own
- K221488: Z7 Zirconia Implant System (2023), 0 descendants of its own

## Indications for use
Z5c implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5c implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them. Z5c implants are intended for delayed loading.

Source page: https://510kreport.com/device/K132881
Methodology: https://510kreport.com/methodology