# K181932: DTX Studio design

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Mar 1, 2019 after 225 days
- Product code: PNP (Dental Abutment Design Software For Dental Laboratory)
- 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: 11 generations back to K894844 (1990). 117 ancestors in all.
No later device cites it as a predicate yet.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151455: 3Shape Abutment Designer Software, 3Shape A/S (2016) Summary page 4.

## Indications for use
DTX Studio design software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. DTX Studio design software is intended to be used by dental laboratory staff or a dental practitioner for designing patient specific component of a two-piece, one-piece or hybrid dental implant abutment. The single or multiple patient specific abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

Source page: https://510kreport.com/device/K181932
Methodology: https://510kreport.com/methodology