# K250156: Choice 2 DC

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Jul 11, 2025 after 171 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002364 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101787: Duolink II, Bisco, Inc. (2010) Summary page 5.

## Indications for use
Choice 2 DC is a dual-cured, resin luting/veneering cement. The indications for use are to cement: 1. Indirect restorations (i.e. crowns, fixed prostheses (bridges), inlay, onlays 2. Endodontic posts 3. Cement-retained implant restorations/abutments (i.e. screws and crowns) 4. Veneers

Source page: https://510kreport.com/device/K250156
Methodology: https://510kreport.com/methodology
