# K191389: Allcem Veneer APS

- Pathway: 510(k) (Traditional)
- Applicant: Dentscare Ltda
- Decided: Feb 25, 2020 after 277 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971372 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142389: Variolink Esthetic, Ivoclar Vivadent, AG (2014) Summary page 4.

## Indications for use
Allcem Veneer APS is an adhesive luting of ceramic and composite restorations (fabricated at the chair-side or in the laboratory) with a low layer thickness (up to 1.5 mm) that enable the use of a purely light-curing technique due to their high translucency. Allcem Veneer Try-in accessory is used to simulate the chromatic effect that will be provided when selected the ideal color of Allcem Veneer cement.

Source page: https://510kreport.com/device/K191389
Methodology: https://510kreport.com/methodology