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Universal Opaque

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131504

by Shofu Dental Corporation

Identifiers

510(k) Number
K131504 FDA 510(k)
FDA Product Code
EBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is a light-cured paste opaques system used for masking and bonding to dental alloys. It consists of a pre-opaque paste and 31 opaque colors, offering excellent masking properties and bond strengths due to optimised microfillers. The thixotropic properties make the pastes soft and flowable, allowing for easy and quick application.

It is supplied as a dental material for use in laboratory or clinical settings involving dental restorations. The device is not described as sterile or single-use in the provided data, and no information is given regarding MRI safety, storage conditions, or reusability. Authorisation is based on FDA 510(k) clearance under k-number K131504, with product code EBF and classification under advisory committee DE (Dental).

Frequently asked questions

What is UNIVERSAL OPAQUE used for?

UNIVERSAL OPAQUE is a light-cured paste opaques system used for masking and bonding to dental alloys in dental restorations, providing excellent masking properties and bond strengths due to optimised microfillers in its formulation.

How is UNIVERSAL OPAQUE supplied and what does it include?

UNIVERSAL OPAQUE is supplied as a dental material consisting of a pre-opaque paste and 31 opaque colors, designed for use in laboratory or clinical settings involving dental restorations, with thixotropic properties that make the pastes soft and flowable for easy application.

Is UNIVERSAL OPAQUE sterile or single-use?

The provided data does not describe UNIVERSAL OPAQUE as sterile or single-use; no information is given regarding sterility, single-use status, or reusability, so users should consult the manufacturer's instructions for specific handling and use guidelines.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SHOFU Universal Opaque - Shofu Dental, Universal Opaque - SHOFU Lab USA, SHOFU Universal Opaque - SHOFU Dental, Shofu Dental Corp. - SHOFU Lab USA, Universal Opaque Pre-Opaque 2ml Shofu - Dentstore

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shofu Dental Corporation

Sources (1)

  • FDA 510(k) K131504 24 fields · synced Sep 26, 2026