# K163640: QZA and RS Dental Implant Systems

- Pathway: 510(k) (Abbreviated)
- Applicant: Trinon Titanium GmbH
- Decided: May 3, 2017 after 131 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 K894595 (1990). 166 ancestors in all.
No later device cites it as a predicate yet.
0 of 167 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142260: NobelActive, Nobel Biocare AB (2015) Summary page 12.
- K160221: Implance Dental Implant System, Implance Dental Abutment System, Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. (2016) Summary page 12.

## Indications for use
TRINON Titanium QZA and RS Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacement to restore patient esthetics and chewing function. TRINON Titanium QZA and RS Dental Implants are indicated for single or multiple unit restorations in non-splinted applications. This can be achieved by a 2-stage surgical technique in combination with delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. TRINON Titanium QZA Dental Implants with a diameter of 3.3 mm may only be used in the upper jaw as a single tooth replacement of the lateral incisors and in the lower jaw as a single tooth replacement of the lateral and central incisors. TRINON QZA and RS abutments are used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. QZA abutment models with an angulation of 30° are indicated for multi-unit loading, such as bridges or overdentures.

Source page: https://510kreport.com/device/K163640
Methodology: https://510kreport.com/methodology