# K053040: Paracem Universal DC

- Pathway: 510(k) (Traditional)
- Applicant: Coltene/Whaledent AG
- Decided: Nov 9, 2005 after 13 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
No predicates in its family tree.
8 later devices descend from it; 4 cite 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer (2008), 3 descendants of its own
- K222581: Stela Automix System (2022), 1 descendant of its own
- K171449: Metacem (2018), 1 descendant of its own
- K261166: Dia-Cem (2026), 0 descendants of its own
- K242097: DenMat Bulk Fill Composite (2024), 0 descendants of its own

## Indications for use
ParaCem Universal DC is indicated for cementing of endodontic posts, crowns, bridges, inlays, onlays, veneers and for core build-ups

Source page: https://510kreport.com/device/K053040
Methodology: https://510kreport.com/methodology