# K150703: CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Aug 13, 2015 after 148 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K221033: UniPrime A, UniPrime E, UniPrime E/C (2022), 0 descendants of its own
- K191523: Visalys Restorative Primer (2019), 0 descendants of its own

## Indications for use
[1] Surface treatment of prosthetic restorations made of ceramic, hybrid ceramics, composite resin or metal [2] Intraoral repairs of fractured restorations made of ceramics, hybrid ceramics, composite resin or metal

Source page: https://510kreport.com/device/K150703
Methodology: https://510kreport.com/methodology