# K101787: Duolink II

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Oct 8, 2010 after 105 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: 3 generations back to K002364 (2000). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934596: Bisco Duo Link D/C Luting Composite, Bisco, Inc. (1994) Summary page 1.
- K040906: Calibra Cement, Dentsply Intl. (2004) Summary page 1.
- K093338: Self Adhesive Composite Luting Cement, Dmg USA, Inc. (2010) Summary page 1.

## Most influential descendants
- K250156: Choice 2 DC (2025), 0 descendants of its own

## Indications for use
DuoLink II is a dual-cured, radio-apparent composite luting cement. The indications of use of DuoLink H are to cement: 1. All indirect restorations (ie. crowns, bridges, inlay, and onlays fabricated from metal composite, porcelain, ceramic, zirconia, alumina, etc) 2. All endodontic posts (ie. fiber, composite, and metal) 3. All abutments (ie. screws)

Source page: https://510kreport.com/device/K101787
Methodology: https://510kreport.com/methodology