# K113376: Neoss Proactive Tapered Implant

- Pathway: 510(k) (Traditional)
- Applicant: Neoss, Ltd.
- Decided: Sep 5, 2012 after 294 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083561: Neoss Proactive Implant, Neoss, Ltd. (2009) Summary page 3.

## Indications for use
The Neoss Tapered Implant is for single-stage or two-stage surgical procedure and cement or screw retained restorations. The Neoss Tapered Implant is intended for immediate placement and function on single tooth and for multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

Source page: https://510kreport.com/device/K113376
Methodology: https://510kreport.com/methodology