# K192053: W Zirconia Implants

- Pathway: 510(k) (Traditional)
- Applicant: Tav Medical, Ltd.
- Decided: Oct 29, 2019 after 90 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 K944964 (1995). 94 ancestors in all.
1 later device descends from it; 1 cites 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)
- K172668: W Zirconia Implants, Tav Medical, Ltd. (2018) Summary page 4.
- K151328: PURE Ceramic Implants, Straumann USA (2016) Summary page 4.
- K180477: Straumann PURE Ceramic Implant System, Institut Straumann AG (2019) Summary page 4.

## Most influential descendants
- K221488: Z7 Zirconia Implant System (2023), 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. The ø3.6mm reduced diameter implants are recommended for central and lateral incisors only.

Source page: https://510kreport.com/device/K192053
Methodology: https://510kreport.com/methodology