# K231859: PrimmaArt

- Pathway: 510(k) (Traditional)
- Applicant: Dentscare Ltda
- Decided: Nov 26, 2024 after 522 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K120779 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120779: Structur 3, Voco GmbH (2012) Summary page 5.

## Indications for use
- Fabrication of temporary crowns, bridges, inlays, onlays and veneers; - Fabrication of long-lasting temporary restorations; - Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal.

Source page: https://510kreport.com/device/K231859
Methodology: https://510kreport.com/methodology