# K172668: W Zirconia Implants

- Pathway: 510(k) (Traditional)
- Applicant: Tav Medical, Ltd.
- Decided: Nov 6, 2018 after 427 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: 11 generations back to K944964 (1995). 91 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151328: PURE Ceramic Implants, Straumann USA (2016) Summary page 5.
- K132881: Z5C, Z-Systems AG (2014) Summary page 5.
- K994119: Synocta Angled Abutments, Straumann USA (2000) Summary page 5.

## Most influential descendants
- 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
- K190406: SDS2.2 dental implant (2020), 0 descendants of its own

## Indications for use
TAV Medical's W Zirconia Implants are intended for surgical placement in the patient's upper and lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K172668
Methodology: https://510kreport.com/methodology