# K180802: Meta P&Bond

- Pathway: 510(k) (Traditional)
- Applicant: Meta Biomed Co., Ltd.
- Decided: Aug 29, 2018 after 154 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: 9 generations back to K931812 (1993). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer, Meta Biomed Co., Ltd. (2008) Summary page 4.

## Indications for use
A dental adhesive formulated to adhesively bond to hard tissues of the oral cavity, enamel and dentin Dentin-enamel primer/bonding agent for direct composite restorations Indirect composite restorative luting system Porcelain veneer luting system Bonding composite to composite Bonding composite to metal/amalgam Adhesive amalgam restorations

Source page: https://510kreport.com/device/K180802
Methodology: https://510kreport.com/methodology