# K150164: Monobond Etch & Prime

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, AG
- Decided: Apr 3, 2015 after 67 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 K090826 (2009). 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)
- K090826: Monobond Plus, Ivoclar Vivadent, Inc. (2009) Summary page 4.

## Indications for use
Conditioning of silica-based ceramic surfaces for the adhesive bond with luting composites

Source page: https://510kreport.com/device/K150164
Methodology: https://510kreport.com/methodology