# K192062: Nucleoss T6 Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST
- Decided: Aug 27, 2020 after 392 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: 14 generations back to K894595 (1990). 222 ancestors in all.
No later device cites it as a predicate yet.
0 of 223 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160850: Nucleoss Tpure Implant System, Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti (2017) Summary page 4.

## Indications for use
Nucleoss T6 Dental Implants are intended to be surgically placed in the bone of the maxillary and/or mandibular arches to provide support for prosthetic restorations (crowns, bridges or overdenture) in edentulous or partially edentulous patients to restore a patients’ chewing function. Nucleoss T6 Dental Implants are intended for delayed loading after 12 weeks. Nucleoss Abutments and Prosthetic parts are intended for use with Nucleoss T6 Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures for edentulous or partially edentulous patients.

Source page: https://510kreport.com/device/K192062
Methodology: https://510kreport.com/methodology