# K253191: DCMhotbond zircon

- Pathway: 510(k) (Traditional)
- Applicant: Dental Creativ Management GmbH
- Decided: May 21, 2026 after 237 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 K920887 (1992). 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)
- K983453: Procera Allceram Fusing Material, Nobel Biocare Uas, Inc. (1998) Summary page 5.

## Indications for use
DCMhotbond zircon is a glass-based ceramic material that is mixed with a modeling liquid. It is intended to be used to fuse together ceramic sections of dental restorations. DCMHotbond zircon liquid is a modeling liquid for mixing with the glassy ceramic solder DCMhotbond zircon.

Source page: https://510kreport.com/device/K253191
Methodology: https://510kreport.com/methodology