# K043168: Biscover LV

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Feb 1, 2005 after 77 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: 1 generation back to K030354 (2003). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030354: Biscover Liquid Polish Kit, Biscover Liquid Polish and Biscover Viscosity Modifier, Bisco, Inc. (2003) Summary page 1.

## Most influential descendants
- K070306: Paint- on Polish Agent (2007), 0 descendants of its own
- K063228: Surface Coat (2006), 0 descendants of its own
- K051999: Biscover Led (2005), 0 descendants of its own

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

Source page: https://510kreport.com/device/K043168
Methodology: https://510kreport.com/methodology