# K091706: Quattro Porcelain System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International, Inc.
- Decided: Aug 28, 2009 after 79 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 K954761 (1995). 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)
- K954761: Finesse Low-Fusing Porcelain System, Dentsply Intl. (1995) Summary page 1.

## Indications for use
Quattro Porcelain System is indicated for: 1. PFM Applications: Single and multiple unit porcelain fused-to-metal fixed prosthodontic restorations. 2. PTM Applications: Single and multiple unit porcelain pressed-to-metal fixed prosthodontic restorations. 3. All-Ceramic Applications: Single unit anterior and posterior premolar metal-free fixed prosthodontic restorations, laminate veneers, inlays and onlays.

Source page: https://510kreport.com/device/K091706
Methodology: https://510kreport.com/methodology