# K191527: Visalys CemCore, Visalys Cem Core Try In Paste

- Pathway: 510(k) (Traditional)
- Applicant: Kettenbach GmbH & Co. KG
- Decided: Nov 8, 2019 after 151 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 K872510 (1987). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143104: Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X, Kettenbach GmbH & Co. KG (2015) Summary page 5.
- K123397: Multilink Automix, Ivoclar Vivadent, AG (2013) Summary page 5.
- K002452: 3M Rely X Veneer Cement Try-in Paster, 3M Company (2000) Summary page 5.

## Indications for use
Visalys® CemCore is a dual-curing, adhesive cementation and core build-up composite, which is intended to be used for: a) Permanent cementation of • crowns, bridges, inlays, onlays, veneers and adhesive bridges made of metal, ceramic, composite, hybrid and oxide ceramics • root posts and indirect core build-ups b) Composite for • adhesive core build-ups Visalys® CemCore Try In Paste is a water-soluble polyethylene glycol paste for shade matching: • To check the shade selected prior to permanent cementation with Visalys® CemCore. • For covering the cement joint to reduce a layer of inhibition.

Source page: https://510kreport.com/device/K191527
Methodology: https://510kreport.com/methodology