# K191591: BB Base 3D printing resin for denture base

- Pathway: 510(k) (Traditional)
- Applicant: Enlighten Materials Co., Ltd.
- Decided: Aug 18, 2020 after 431 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.
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
Enlighten BB Base, developed by ENLIGHTEN MATERIALS Co., Ltd., is a light-cured resin indicated for the fabrication of full removable denture bases in dental laboratories. It is an alternative to traditional heat-cured, auto-cured or light-cured denture base resins. Enlighten BB Base should be used exclusively by dental professionals. Fabrication of denture bases with Enlighten BB Base requires a computer-aided and manufacturing (CAD/CAM) system including the following; optical impression system, design software (CAD software), stereolithographic additive printer, and post-cure unit.

Source page: https://510kreport.com/device/K191591
Methodology: https://510kreport.com/methodology