# K070019: Carrara Volumia

- Pathway: 510(k) (Special)
- Applicant: Dentsply Intl.
- Decided: Jan 26, 2007 after 23 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: 2 generations back to K981000 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040635: Carrara Interaction Ceramic System, Dentsply Intl. (2004) Summary page 1.

## Indications for use
Carrara Volumia Ceramic System is indicated for veneering of metal-ceramic or full ceramic restorative systems.

Source page: https://510kreport.com/device/K070019
Methodology: https://510kreport.com/methodology