# K193436: VITA Ambria

- Pathway: 510(k) (Traditional)
- Applicant: Vita Zahnfabrik GmbH H Rauter & CO
- Decided: May 14, 2020 after 155 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- 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 K050362 (2005). 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)
- K050362: Vita PM 7 (20 Gram Bottles), Vita PM 7 (50 Gram Bottles), Vident (2005) Summary page 5.

## Indications for use
VITA AMBRIA are zirconia-reinforced lithium silicate press pellets for the fabrication of restorations in the press technique. Indications •Occlusal veneers (table tops), veneers •Inlays, onlays, partial crowns •Crowns in the anterior and posterior areas •3-unit anterior bridges up to the second premolar •Single tooth restorations as implant suprastructures for anterior and posterior teeth •3-unit bridges as implant suprastructures up to the second premolar •Single tooth mesostructures in the anterior and posterior areas •Abutment crowns in the anterior and posterior areas

Source page: https://510kreport.com/device/K193436
Methodology: https://510kreport.com/methodology