# K030859: Nova Ceramic Spray Glaze and Tru-Paque, Opaque Porcelain

- Pathway: 510(k) (Special)
- Applicant: Enamelite, LLC
- Decided: Mar 27, 2003 after 9 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: 1 generation back to K895889 (1990). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895889: Shake N' Spray (W/Silhouette Porcelain), Leach and Dillon Co., Inc. (1990) Summary page 1.

## Most influential descendants
- K160099: CEREC SpeedGlaze (2016), 1 descendant of its own
- K202629: Dentsply Sirona Universal Spray Glazes (2021), 0 descendants of its own
- K103494: Zenostar Magic Glaze (2011), 0 descendants of its own

## Indications for use
The Enamelite Porcelain Powders are aerosol devices intended to be used as spray applications of ceramic porcelains and glazes for dental restorations (crowns and bridges), which are produced in dental laboratories.

Source page: https://510kreport.com/device/K030859
Methodology: https://510kreport.com/methodology