# K023742: Sculpture Plus Nano-Hybrid Composite

- Pathway: 510(k) (Traditional)
- Applicant: Pentron Laboratory Technologies
- Decided: Jan 17, 2003 after 71 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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 K932154 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932154: Conquest Crystal, Jeneric/Pentron, Inc. (1993) Summary page 1.

## Indications for use
Sculpture Plus Nano-Hybrid Composite is an indirect or diredindirect dental restorative material. It is indicated for use, in cured form, to restore carious lesions or structural defects or lost tooth structure either by itself or in combination of metal/ceramic/polymeric substrates and conditioners such as bonding, luting, etching agents commonly used in tooth restoration. The curing can be processed using photo and/or heat curing devices. The curing can accomplished in air, under vacuum or under pressure without or with inert atmosphere.

Source page: https://510kreport.com/device/K023742
Methodology: https://510kreport.com/methodology