# K090452: Neoss Implant System 03.25

- Pathway: 510(k) (Traditional)
- Applicant: Neoss, Ltd.
- Decided: May 22, 2009 after 88 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: 4 generations back to K891615 (1989). 12 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043195: Neo Implant System, Neoss, Ltd. (2005) Summary page 2.
- K083561: Neoss Proactive Implant, Neoss, Ltd. (2009) Summary page 2.
- K071838: Neoss Various Titanium Abutments, Neoss, Ltd. (2007) Summary page 2.

## Most influential descendants
- K183024: Implacil Implant System (2020), 2 descendants of its own
- K202832: Implacil Implant System (2021), 0 descendants of its own
- K192839: DSP Implant System (2021), 0 descendants of its own

## Indications for use
The Neoss Implant System 03,25 is for single-stage and two-stage surgical procedures and cement or screw retained restorations. The Neoss Implant System 03,25 are intended for immediate loading on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar. The Neoss Implant 03,25 abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.

Source page: https://510kreport.com/device/K090452
Methodology: https://510kreport.com/methodology