# K222414: Tera Harz Denture

- Pathway: 510(k) (Traditional)
- Applicant: Graphy, Inc.
- Decided: Aug 11, 2022 after 1 day
- 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: 1 generation back to K162044 (2017). 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)
- K162044: Dentca Denture Base II, Dentca, Inc. (2017) Summary page 4.

## Indications for use
The TERA HARZ DENTURE is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with the TERA HARZ DENTURE requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, digital light processing(DLP) printer, and curing light equipment.

Source page: https://510kreport.com/device/K222414
Methodology: https://510kreport.com/methodology