# K251587: VITA VMLC Primer

- Pathway: 510(k) (Traditional)
- Applicant: Vita Zahnfabrik H. Rauter GmbH & Co. Kg.
- Decided: Feb 23, 2026 after 276 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: 6 generations back to K902115 (1990). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974089: Alloy Primer, Kuraray America, Inc. (1997) Summary page 5.
- K240660: Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active, Kulzer, LLC (2024) Summary page 5.

## Indications for use
* Adhesive bonding of metal substructure surfaces (non-precious metal alloys, PM alloys, titanium) with (meth-)acrylate-based resins/composites * Adhesive bonding of ZrO2 substructure surfaces with (meth-)acrylate-based resins/composites * Adhesive bonding of cross-linked composites/resins such as VITA CAD Temp or of high-performance polymers (PEEK, PEKK) with (meth-)acrylate-based resins/composites

Source page: https://510kreport.com/device/K251587
Methodology: https://510kreport.com/methodology