# K043195: Neo Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Neoss, Ltd.
- Decided: Mar 7, 2005 after 109 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: 2 generations back to K891615 (1989). 6 ancestors in all.
167 later devices descend from it; 6 cite it directly.
0 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041492: Astra Tech Implants - Dental System, Astra Tech, Inc. (2004) Summary page 1.
- K931767: Astra Tech Implants-Dental System, Astra Tech, Inc. (1994) Summary page 1.
- K974738: Astra Tech Implant Dental System, Astra Tech, Inc. (1998) Summary page 1.
- K962014: 3I Single Use, Disposable Drills,Taps,Burs, Etc., Implant Innovations, Inc. (1996) Summary page 1.

## Most influential descendants
- K120954: Nobelprocera Peek Abutments (2013), 105 descendants of its own
- K133731: Nobelactive Wide Platform (WP) (2014), 101 descendants of its own
- K142260: NobelActive (2015), 99 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K071838: Neoss Various Titanium Abutments (2007), 74 descendants of its own

## Indications for use
The Neo Implants - Neo Implant System are for single-stage and two-stage surgical procedures and cement or screw retained restorations. The Neo Implants - Neo Implant System are intended tor immediate placement and function 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.

Source page: https://510kreport.com/device/K043195
Methodology: https://510kreport.com/methodology