# K182908: Ziacom Dental Implant Systems

- Pathway: 510(k) (Traditional)
- Applicant: Ziacom Medical, S.L.
- Decided: Jul 18, 2019 after 274 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: 12 generations back to K894595 (1990). 150 ancestors in all.
No later device cites it as a predicate yet.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 4.

## Indications for use
Ziacom Dental Implant Systems are intended to be surgically placed in the bone of the mandibular or maxillary jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function and to aid in prosthetic rehabilitation. Ziacom Dental Implant Abutments are intended to be used with Ziacom Dental Implants to aid in prosthetic rehabilitation. The intended use for Ziacom Dental Implant Zinic® NP 3.30mm diameter is limited to replacement of mandibular incisors.

Source page: https://510kreport.com/device/K182908
Methodology: https://510kreport.com/methodology