# K220680: Denture Base Polymers

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Huge Dental Material Corporation
- Decided: Aug 12, 2022 after 157 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: 3 generations back to K901789 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102654: Vertex Rapid Simplified, Vertex-Dental B.V. (2010) Summary page 4.
- K102640: Vertex Self Curing, Vertex Castavaria, Vertex Castapress, Vertex-Dental B.V. (2011) Summary page 4.

## Indications for use
Denture Base Polymers is used for fabrication and repair of partial and full denture base for patients with missing teeth.

Source page: https://510kreport.com/device/K220680
Methodology: https://510kreport.com/methodology