# K183465: Allcem, Allcem Core

- Pathway: 510(k) (Traditional)
- Applicant: Dentscare Ltda
- Decided: Nov 2, 2019 after 323 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: 11 generations back to K931812 (1993). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110508: Suglue-10, 3M Espe AG (2011) Summary page 5.

## Indications for use
Allcem and Allcem Core are indicated for the cementation of indirect restorations of the tooth structure. It can be used for luting: - Porcelain fused-to-metal crowns and bridges; - Metal crowns, bridges, inlays and onlays (high noble, noble, and base metals); - Crowns and bridges with minimal tooth structure; - Maryland bridges (resin bonded bridges); - All ceramic/porcelain and pre-cured composite crowns, bridges, inlays and onlays; - Endodontic posts; * Only for Allcem Core: Core build-up.

Source page: https://510kreport.com/device/K183465
Methodology: https://510kreport.com/methodology