# K040906: Calibra Cement

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Jun 16, 2004 after 70 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: 1 generation back to K940459 (1994). 1 ancestor in all.
8 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940459: Multipurpose Resin Cement with Fluoride (MRCF), Dentsply Intl. (1994) Summary page 1.

## Most influential descendants
- K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer (2008), 3 descendants of its own
- K171449: Metacem (2018), 1 descendant of its own
- K101787: Duolink II (2010), 1 descendant of its own
- K083326: Fluorocore 2 (2009), 1 descendant of its own
- K261166: Dia-Cem (2026), 0 descendants of its own

## Indications for use
Adhesive cementation of: 1) ceramic, porcelain, or composite inlays/onlays, veneers, or crowns; 2) all metal crowns, bridges, inlays/onlays including precious, semi-precious, and non-precious metals; 3) PFM (porcelain fused to metal) crowns and bridges; 4) prefabricated and cast posts; and 5) resin-bonded retainer bridges (Maryland bridges)

Source page: https://510kreport.com/device/K040906
Methodology: https://510kreport.com/methodology