# K160099: CEREC SpeedGlaze

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Jun 2, 2016 after 135 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: 2 generations back to K895889 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030859: Nova Ceramic Spray Glaze and Tru-Paque, Opaque Porcelain, Enamelite, LLC (2003) Summary page 4.

## Most influential descendants
- K202629: Dentsply Sirona Universal Spray Glazes (2021), 0 descendants of its own

## Indications for use
Glazing of individually designed dental restorations from dental ceramics. The CEREC SpeedGlaze Spray is used for coating dental restorations made from Sirona CAD/CAM materials. It is administered extra-orally and is indicated for crowns, inlays, onlays, partial crowns and bridges in the anterior and posterior tooth region.

Source page: https://510kreport.com/device/K160099
Methodology: https://510kreport.com/methodology