# K222489: Harvest Printable Resin

- Pathway: 510(k) (Traditional)
- Applicant: Harvest Dental Products, LLC
- Decided: May 12, 2023 after 268 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K924830 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162572: NextDent Denture, E-Denture, Vertex-Dental B.V. (2017) Summary page 4.
- K201173: E-Guard, Envisiontec GmbH (2020) Summary page 4.

## Indications for use
Harvest Printable Resin is indicated for the fabrication of dental bases for full removable dentures, artificial teeth, dental bite splints and guards and try-in devices, i.e., denture base and teeth. The material is an alternative to traditional heat-curable and auto-polymerizing resins and is intended for professional dental work only. This material is intended to be used by dental lab technicians and approved by licensed practitioners before being provided to the patient.

Source page: https://510kreport.com/device/K222489
Methodology: https://510kreport.com/methodology