# K191524: Visalys Tooth Primer

- Pathway: 510(k) (Traditional)
- Applicant: Kettenbach GmbH & Co. KG
- Decided: Sep 29, 2019 after 111 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: 13 generations back to K931812 (1993). 77 ancestors in all.
No later device cites it as a predicate yet.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150704: PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer, Kuraray Noritake Dental, Inc. (2015) Summary page 5.

## Indications for use
For permanent cementation of tooth structure to: • crowns, bridges, inlays, onlays, veneers and adhesive bridges in combination with Visalys® CemCore • root posts in combination with Visalys® CemCore and Visalys® Core • indirect core build-ups in combination with Visalys® CemCore For build-up adhesive bond to structure with Visalys® CemCore and Visalys® Core to fabricate: • adhesive core build-ups

Source page: https://510kreport.com/device/K191524
Methodology: https://510kreport.com/methodology