# K160850: Nucleoss Tpure Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti
- Decided: Aug 4, 2017 after 494 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: 13 generations back to K894595 (1990). 221 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 224 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140878: Straumann Bone Level Tapered Implant, Straumann USA, LLC (2014) Summary page 4.
- K151194: Klockner Dental Implant Abutments (II), Soadco, S.L. (2016) Summary page 4.
- K122988: Klockner Dental Implant Abutments, Soadco, S.L. (2013) Summary page 4.
- K141544: Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant System, Zimmer Dental, Inc. (2014) Summary page 4.

## Most influential descendants
- K231100: Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw (2024), 0 descendants of its own
- K192062: Nucleoss T6 Dental Implant System (2020), 0 descendants of its own

## Indications for use
Nucleoss Tpure Implant System are medical devices 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 Tpure Dental Implants are intended for delayed loading after 12 weeks. Nucleoss Abutments and Prosthetic parts are intended for use with Nucleoss Tpure Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdenture for edentulous or partially edentulous patients.

Source page: https://510kreport.com/device/K160850
Methodology: https://510kreport.com/methodology