510(k) Report

510(k) · Cleared

Cleared

Feniiiiiix Coloration Kit

K060086510(k) TraditionalCleared Mar 3, 200651-day reviewClass II21 CFR 872.6660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dental Arte, Inc. · EIH Powder, Porcelain

Cleared on Mar 3, 2006 after a 51-day review. The FDA summary names no predicate by number.

Decided
Mar 3, 2006
Review
51 days
Class
Class II
Product code
EIH
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K060086Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new EIH device

  1. #1 K192231 Dental Glass Ceramics Blocksscore 15.2 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All EIH devices

EIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EIH

13in 2025

2007: 152008: 152009: 152010: 142011: 142012: 92013: 162014: 182015: 232016: 222017: 162018: 102019: 162020: 132021: 172022: 162023: 152024: 282025: 132026 (partial year): 14
2007high 28 (2024) · low 9 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EIH

84in 2025

2007: 63 days median2008: 87 days median2009: 79 days median2010: 89 days median2011: 80 days median2012: 96 days median2013: 107 days median2014: 118 days median2015: 118 days median2016: 187 days median2017: 149 days median2018: 139 days median2019: 125 days median2020: 155 days median2021: 131 days median2022: 89 days median2023: 114 days median2024: 89 days median2025: 84 days median2026 (partial year): 73 days median
2007high 187 (2016) · low 63 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EIH

1in 2025

2016: 212025: 1
2007high 21 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EIH

1in 2025

2008: 12011: 12013: 62014: 12016: 42017: 12018: 22019: 12021: 222024: 72025: 1
2007high 22 (2021) · low 0 (2007)2025

MAUDE reports naming product code EIH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007156300
2008158701
2009157900
2010148900
2011148001
201299600
20131610706
20141811801
20152311800
201622187214
20171614901
20181013902
20191612501
20201315500
202117131022
2022168900
20231511400
2024288907
2025138411
202614730—

What is it indicated for?

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…

Read the full statement (286 words)

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.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K060086: Feniiiiiix Coloration Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060086

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026