# K250393: ZircaGlow & ZircaGlow HT Zirconia

- Pathway: 510(k) (Traditional)
- Applicant: United Zirconia
- Decided: May 12, 2025 after 89 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 K190079 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190079: ArgenZ HT+, The Argen Corporation (2019) Summary page 5.

## Indications for use
ZircaGlow & ZircaGlow HT Zirconia blanks are indicated for use by dental technicians for the production of full contour and substructures restorations up to a full arch

Source page: https://510kreport.com/device/K250393
Methodology: https://510kreport.com/methodology