# K193352: AbutmentCAD

- Pathway: 510(k) (Traditional)
- Applicant: Exocad GmbH
- Decided: Jul 21, 2021 after 595 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
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result 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/K193352
Methodology: https://510kreport.com/methodology