# K131504: Universal Opaque

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corporation
- Decided: Jul 16, 2013 after 53 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
UNIVERSAL OPAQUE is a light-owing resin paste to be used for masking the substructure color of dental restorations. 1) Masking the metal color of facing crown 2) Masking the substructure color of jacket crown and laminate veneer etc. 3) Masking the substructure color of restorations and prostheses made of porcelain or crown and bridge composite resin etc. when repairing them intraorally or extraorally.

Source page: https://510kreport.com/device/K131504
Methodology: https://510kreport.com/methodology