# K220042: Dentca Base Premium, Dentca Base Hi-Impact

- Pathway: 510(k) (Traditional)
- Applicant: Dentca, Inc.
- Decided: Nov 17, 2022 after 316 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: 5 generations back to K011560 (2001). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190043: Halley resin, Dentsply Sirona (2019) Summary page 4.

## Most influential descendants
- K260569: DB 4000 High Impact Denture Base (2026), 0 descendants of its own
- K260376: Denture Base (2026), 0 descendants of its own

## Indications for use
DENTCA Base Resin is a light-curable resin indicated for the fabrication and repair of removable denture bases in dental laboratories, including full and partial dentures as well as immediate dentures, and baseplates. DENTCA Base Resin can also be used for the fabrication of try-in dentures for the evaluation before fabricating the final dentures. Fabrication of these prostheses with DENTCA Base Resin requires a digital denture file, additive printer, and curing light equipment. DENTCA Base Resin can be utilized as an aid in bonding the denture teeth onto denture base.

Source page: https://510kreport.com/device/K220042
Methodology: https://510kreport.com/methodology