# K231529: CloudPoint FastDesign Chairside

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Mar 14, 2024 after 293 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: 12 generations back to K894844 (1990). 118 ancestors in all.
No later device cites it as a predicate yet.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200100: Abutment Design, 3Shape A/S (2020) Summary page 5.

## Indications for use
CloudPoint FastDesign Chairside is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. CloudPoint FastDesign Chairside is intended for use by a dental practitioner or dental laboratory staff for designing the patient-matched component of a two-piece hybrid dental implant abutment. The resulting 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/K231529
Methodology: https://510kreport.com/methodology