# K043562: BC Plus

- Pathway: 510(k) (Traditional)
- Applicant: Vericom Co., Ltd.
- Decided: Jan 3, 2005 after 7 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 K992985 (1999). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992985: Gluma Comfort Bond, Heraeus Kulzer, Inc. (1999) Summary page 1.

## Most influential descendants
- K192392: DiaPlus (2020), 1 descendant of its own
- K210421: Diafil & Diafil Capsule (2021), 0 descendants of its own

## Indications for use
BC PlusTM is a light curing single component bonding agent specially developed as a restorative adhesive in dentistry, which is used for bonding resin-based filling materials (e.g. composites, compomers) to hard dental tissues. Other indications include bonding of amalgam and laboratory-produced restorations. BC PIusTM permits priming and bonding to be carried out in single step.

Source page: https://510kreport.com/device/K043562
Methodology: https://510kreport.com/methodology