# K061322: Porcelain Primer

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: Jun 2, 2006 after 22 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer (2008), 3 descendants of its own
- K171449: Metacem (2018), 1 descendant of its own
- K261166: Dia-Cem (2026), 0 descendants of its own
- K180802: Meta P&Bond (2018), 0 descendants of its own
- K091300: Ascent Porcelain Primer, Model 006-00078, 00600079 (2009), 0 descendants of its own

## Indications for use
Porcelain primer is an agent for enhancing bonds to porcelain, ceramic, procured composites and surfaces of non-precious metals. When prepared with a thin layer of Porcelain Primer, the areas are ready for bonding with acrylic resins. Suitable acrylic resins are bonding resins, flowable composites or composite resins. The use of rubber dam is strongly recommended during intraoral work.

Source page: https://510kreport.com/device/K061322
Methodology: https://510kreport.com/methodology