# K200580: FotoDent denture

- Pathway: 510(k) (Abbreviated)
- Applicant: Dreve Dentamid GmbH
- Decided: Nov 19, 2020 after 259 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: 1 generation back to K162044 (2017). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K233995: Ivotion Base Print (2024), 0 descendants of its own

## Indications for use
FotoDent® denture is a light curing resin intended for manufacturing of full and partial removable dentures.

Source page: https://510kreport.com/device/K200580
Methodology: https://510kreport.com/methodology