# K171466: NobelDesign, DTX Studio Design

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Nov 29, 2017 after 195 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: 5 generations back to K000018 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153036: NobelDesign Software, Nobel Biocare AB (2016) Summary page 5.

## Indications for use
The software is intended to be used at a dental clinic or a dental laboratory. The software uses patient-specific data from scanners, e.g. a scanned geometry, and facilitates the CAD of individual restorative solutions based on these data, such as a supporting dental framework, dental abutments, copings, crowns, and bridges. The software also serves as a means of creating and managing of cases, and the ordering of products.

Source page: https://510kreport.com/device/K171466
Methodology: https://510kreport.com/methodology