# K153036: NobelDesign Software

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Jun 2, 2016 after 227 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- 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 K000018 (2000). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053602: Procera Software, Model 33145, Nobel Biocare AB (2006) Summary page 4.

## Most influential descendants
- K171466: NobelDesign, DTX Studio Design (2017), 0 descendants of its own

## Indications for use
The NobelDesign Software uses patient-specific data from scanners and defines the shapes of dental prosthetic devices such as dental abutments, copings and bridges through the use of a CAD tool. The software also serves as a means of creating, ordering and managing cases.

Source page: https://510kreport.com/device/K153036
Methodology: https://510kreport.com/methodology