# K202629: Dentsply Sirona Universal Spray Glazes

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Jan 20, 2021 after 131 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: 3 generations back to K895889 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160099: CEREC SpeedGlaze, Sirona Dental Systems GmbH (2016) Summary page 4.

## Indications for use
Dentsply Sirona Universal Spray Glazes are aerosol glazing porcelains used to glaze high-strength glass ceramic and zirconia dental restorations. The glaze sprays are applied to restorations and fired.

Source page: https://510kreport.com/device/K202629
Methodology: https://510kreport.com/methodology