# K042804: Tescera Opaquer Powder/Sculpting Resin

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Feb 1, 2005 after 112 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 K874557 (1988). 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)
- K874557: Bisco Porcelain Repair Kit, Bisco, Inc. (1988) Summary page 1.
- K030585: Sculpting Resin, Bisco, Inc. (2003) Summary page 1.

## Indications for use
TESCERA Opaquer/Sculpting Resin is a pre-wetting agent for placing and sculpting layers of composites. When mixed with TESCERA Opaquer Powder, TESCERA Opaquer/Sculpting Resin is a dual-cured material (light/heat) used to opaque/mask metal substrates and other materials used in dental restorations.

Source page: https://510kreport.com/device/K042804
Methodology: https://510kreport.com/methodology