# K051999: Biscover Led

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Aug 22, 2005 after 28 days
- Product code: EBD (Coating, Filling Material, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K030354 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043168: Biscover LV, Bisco, Inc. (2005) Summary page 1.

## Indications for use
BISCOVER LED is a low-viscosity, light-cured resin formulation used to seal restorations and enamel while leaving a smooth polished surface. BISCOVER LED is used to Seal and Polish: 1. Direct composites (cured) 2. Indirect composites 3. Provisionals 4. Acrylic appliances 5. Resin-modified Glass Ionomers 6. Enamel before or after orthodontic bracket placement 7. Etched Enamel

Source page: https://510kreport.com/device/K051999
Methodology: https://510kreport.com/methodology