# K162044: Dentca Denture Base II

- Pathway: 510(k) (Traditional)
- Applicant: Dentca, Inc.
- Decided: Mar 3, 2017 after 221 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
No predicates in its family tree.
16 later devices descend from it; 6 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K221678: SprintRay High Impact Denture Base (2022), 5 descendants of its own
- K210298: GR-14 Resin System (2021), 3 descendants of its own
- K230445: OnX Tough (2023), 2 descendants of its own
- K213765: Glidewell 3DP Denture Base Resin (2022), 2 descendants of its own
- K240688: RODIN Titan 3D Resin (2024), 1 descendant of its own

## Indications for use
DENTCA Denture Base II 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 Dentca Denture Base II requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, stereolithographic additive printer, and curing light equipment.

Source page: https://510kreport.com/device/K162044
Methodology: https://510kreport.com/methodology