# K110719: Origin Zirconia

- Pathway: 510(k) (Abbreviated)
- Applicant: B&D Dental Technologies
- Decided: Aug 11, 2011 after 149 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Origin Zirconia Dental Material is an integrated system of dental ceramic which supports dental restorations and which are milled into prosthetic devices such as Crowns, Bridges, and Copings for partial and fully edentulous patients. The material can be milled into a variety of customized dental restorations to meet the specific needs of individual dental patients. Each patient is named by a physician or dentists written prescription specifying the type of restoration to be produced. Origin Zirconia is intended to be used as a biocompatible material to be milled into precise customized dental restoration units for either crowns, copings or bridges which may be further processed by the addition of ceramic layering to create aesthetic lifelike restorations. Origin Zirconia is intended to be used as prescribed by a qualified and licensed physician or dentist by a written prescription which names the patient for which each individual dental restoration is to be produced.

Source page: https://510kreport.com/device/K110719
Methodology: https://510kreport.com/methodology