# K041272: Dyract Cem Plus Cement

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Oct 18, 2004 after 159 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 K950991 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933139: 3M Vitremer Luting Cement, 3M Company (1994) Summary page 1.
- K982395: Dytract Flow Restorative, Dentsply Intl. (1998) Summary page 1.

## Indications for use
1. Cementation of conventional metal or porcelain-fused-to-metal inlays, onlays, crowns, bridges, posts and post-core units 2. Adhesive cementation of porcelain, composite, or all-ceramic inlays, onlays and crowns 3. Cementation of all-zirconia bridges

Source page: https://510kreport.com/device/K041272
Methodology: https://510kreport.com/methodology