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Triad Inlay Composite

by Dentsply Intl.

510(k) K923236

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK923236 Date11 Sep 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Triad Inlay Composite is a dental restorative material classified as a resin-based composite (product code EBF). It is designed for use in dental inlays, providing durable and aesthetically pleasing restorations that match natural tooth shade. This material is intended for permanent restorations in posterior teeth, offering mechanical strength and chemical resistance to ensure long-term performance in the oral environment.

Supplied as pre-mixed sheets, ropes, gels, and pastes, the Triad Inlay Composite is intended for single-use applications in dental offices. It is cured using visible light technology, which enhances stability and minimizes polymerization shrinkage. The device is regulated under FDA 510(k) clearance (K923236) and falls under Class II – Special Controls for dental materials. No sterility or MRI safety information is specified in the provided data.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Triad Inlay Composite used for?

    The Triad Inlay Composite is designed specifically for permanent restorations in posterior teeth, such as molars and premolars. It provides durable, aesthetically pleasing inlays that closely match natural tooth shade, ensuring both functionality and appearance. Its resin-based formulation delivers mechanical strength and chemical resistance, making it suitable for long-term use in the oral environment.

  • How is the Triad Inlay Composite supplied, and is it single-use?

    The Triad Inlay Composite is supplied in pre-mixed forms, including sheets, ropes, gels, and pastes, which are intended for single-use applications in dental offices. This pre-mixed format simplifies handling and ensures consistency in restoration quality, while the single-use nature reduces cross-contamination risks.

  • Does the Triad Inlay Composite require any special curing process?

    Yes, the Triad Inlay Composite is cured using visible light technology. This curing method enhances the material’s stability and minimizes polymerization shrinkage, which helps improve the longevity and fit of the restoration. The visible-light curing process is standard for resin-based composites and ensures optimal hardening of the material.

  • Are there different sizes or models available for the Triad Inlay Composite?

    The Triad Inlay Composite is supplied in various pre-mixed forms (sheets, ropes, gels, and pastes), which cater to different clinical needs and restoration sizes. While specific size ranges or model references aren’t detailed in the data, the versatility of these forms allows dentists to select the appropriate format based on the patient’s tooth anatomy and the restoration’s requirements.

  • How should the Triad Inlay Composite be stored?

    The storage conditions for the Triad Inlay Composite are not explicitly detailed in the provided data, but resin-based composites like this typically require protection from moisture, extreme temperatures, and direct light. It is generally recommended to store the material in a cool, dry place, sealed to prevent contamination, until ready for use. Always follow the manufacturer’s guidelines for optimal shelf life.