# K221033: UniPrime A, UniPrime E, UniPrime E/C

- Pathway: 510(k) (Traditional)
- Applicant: S&C Polymer Silicon- Und Composite Spezialitäten GmbH
- Decided: Jul 6, 2022 after 90 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
UniPrime A is a MDP containing universal primer 1) for the bonding of methacrylate based dental materials to zirconia and metal/alloy frameworks, crowns and bridges and 2) for the intraoral repair of fractured restorations made of zirconia and metal/alloy. UniPrime E is a MDP containing universal primer 1) for the bonding of methacrylate based dental materials to zirconia, composite and metal/alloy frameworks, crowns and bridges and 2) for the intraoral repair of fractured restorations made of zirconia, composite and metal/alloy. UniPrime E/C is a MDP containing universal primer 1) for the bonding of methacrylate based dental materials to ceramic, zirconia, composite and metal/alloy frameworks, crowns and bridges and 2) for the intraoral repair of fractured restorations made of ceramic, zirconia, composite and metal/alloy.

Source page: https://510kreport.com/device/K221033
Methodology: https://510kreport.com/methodology