# K060086: Feniiiiiix Coloration Kit

- Pathway: 510(k) (Traditional)
- Applicant: Dental Arte, Inc.
- Decided: Mar 3, 2006 after 51 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. The FDA summary names no predicate by number.

## Indications for use
FENIIIIIIX system includes the following 6 sets of stains and dental porcelains: FENIIIIIIX COLORATIONKITSN2000Ya 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 FENIIIIIIX COLORATION KIT stain system 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 SN2000Y kit fire at 90000 FENIIIIIIX COLORATION KIT SN200Y is identical to the SN2000Y kit in function and content except that the stains in the SN2000Y kit fire at 7500 C FENIIIIIIX SUPER LIGHT WHITE KIT, a stain kit designed to produce perfectly white dental restorations. It includes one powdered stain and 1 liquid glaze FENIIIIIIX SPEACIAL CLEAR KIT, This kit includes a series of whites designed to produce areas of whitish translucence and opalescence. ASTARTE SUPER WHITE PORCELAIN KIT. This kit is specifically designed to create perfectly white dental restorations and can be used with most commercially available base and precious metal, dental alloys that are designed for porcelain fused to metal applications. It includes 1 powdered opaque, 1 powdered enamel, 1 powdered colorless glaze, 1 liquid opaque and 1 liquid dentine. FEN/IIIIIX ELIMINCRACK. This kit is used to repair cracks that form in porcelain dental restorations. It includes 1 powdered porcelain and 1 repair liquid.

Source page: https://510kreport.com/device/K060086
Methodology: https://510kreport.com/methodology