# K191523: Visalys Restorative Primer

- Pathway: 510(k) (Traditional)
- Applicant: Kettenbach GmbH & Co. KG
- Decided: Oct 9, 2019 after 121 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- 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 K150703 (2015). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150703: CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial), Kuraray Noritake Dental, Inc. (2015) Summary page 5.

## Indications for use
Restoration primer for treatment of: metal/silicate ceramics, oxide ceramic and composite surfaces • to cement prosthetic restorations • to repair fractured restorations with composite materials

Source page: https://510kreport.com/device/K191523
Methodology: https://510kreport.com/methodology