# K171167: Prodigio Stain Powder

- Pathway: 510(k) (Traditional)
- Applicant: Operart, LLC
- Decided: Dec 13, 2017 after 236 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 Prodigio Stain Powder includes the following 6 sets of stains and dental porcelains: Prodigio Stain Kit is a porcelain stain system designed for easy application and natural fluorescent properties. This dental porcelain stain system can be used with most commercially available porcelain restorations, where porcelain's ability to mimic natural tooth appearance is important. The system provides optimum esthetics with the most consistently reliable results for the full range of shades. The Prodigio Stain Kit is ideal for high and low production laboratories and is available in 16 classic Vita® shades as well as Neutral Brown, Complex Gray, Blue Gray, Ochre; Rust and Red for matching bleached dentition with CTE Ranges of 13.7 to 15.1. The full assortment is 22 Stains, 1 powdered glaze and 1 liquid glaze. The stains in the Prodigio Stain Kit fire at 900 degrees C Prodigio Stain Kit is identical to the SN2000Y kit in function and content except that the stains in the SN2000Y kit fire at 750 degrees C

Source page: https://510kreport.com/device/K171167
Methodology: https://510kreport.com/methodology