# K030585: Sculpting Resin

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Apr 28, 2003 after 63 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
No predicates in its family tree.
3 later devices descend from it; 3 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Ultradent Composite Wetting Resin: named in the summary without a submission number

## Most influential descendants
- K092730: Cosmedent Brushable Composite (2009), 0 descendants of its own
- K092539: Seamfree (2009), 0 descendants of its own
- K042804: Tescera Opaquer Powder/Sculpting Resin (2005), 0 descendants of its own

## Indications for use
The intended use of Bisco's Sculpting Resin is as a pre-wetting agent for placing and sculpting layers of composites and between layers of cured composite

Source page: https://510kreport.com/device/K030585
Methodology: https://510kreport.com/methodology