# K222961: Harvest Conceal ZR Block Out

- Pathway: 510(k) (Traditional)
- Applicant: Harvest Dental Products, LLC
- Decided: Jun 2, 2023 after 248 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: 4 generations back to K123680 (2013). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173769: DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid, Dmax Co., Ltd. (2018) Summary page 4.

## Indications for use
Harvest Conceal ZR Block Out is indicated for burn-in zirconia shading. The applied liquid is sintered with the zirconia to adjust the restoration to match the natural color of the patient's teeth. The material is intended for professional dental work only.

Source page: https://510kreport.com/device/K222961
Methodology: https://510kreport.com/methodology