# K964000: Bisfil 2B

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Nov 5, 1996 after 29 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.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bisfil II: named in the summary without a submission number

## Most influential descendants
- K012307: Luxacore/Luxacore Dual (2001), 9 descendants of its own
- K143104: Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X (2015), 1 descendant of its own
- K092572: Core*IT Dual (2009), 1 descendant of its own
- K041960: Composite/Compomer Repair Kit (2004), 1 descendant of its own
- K262982: Core·it Dual (2026), 0 descendants of its own

## Indications for use
BISFIL 2B is indicated for use as a base increment posterior composite. It is intended to be used with ALL-BOND 2® or ONE-STEP™, or similar universal dental adhesive system. BISFIL 2B will bond to the enamel / dentin bonding system such as ONE-STEP. BISFIL 2B is intended to be covered by a high quality light-cure composite.

Source page: https://510kreport.com/device/K964000
Methodology: https://510kreport.com/methodology