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Adhesive Hybrid Ionomer Cement

by Dentsply Intl.

510(k) K974140

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 NumberK974140 Date5 Jan 1998ClearedStatusActive

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  • Withdrawn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
EMA
Device Class
Class II
Regulation
21 CFR Part 872.3275
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

Adhesive Hybrid Ionomer Cement is a dental cement used for the permanent cementation of crowns, bridges, inlays, onlays, and posts. It also functions as an adhesive liner for direct amalgam restorations and provides a protective barrier while releasing fluoride.

This two-component, dual-cure device is applied by dental professionals in clinical settings. The material is designed to adhere to dentin and enamel upon curing. This device is authorized under FDA 510(k) clearance K974140.

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Questions

AI-generated answers, 26 Sep 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 primary clinical use for this cement?

    This device is indicated for the permanent cementation of dental restorations, including crowns, bridges, inlays, onlays, and posts. Additionally, it serves as an adhesive liner for direct amalgam restorations.

  • How does this material interact with the tooth structure?

    The material is a dual-cure, two-component system designed to adhere directly to both dentin and enamel upon curing, ensuring a stable bond for the restoration.

  • Does this cement provide any additional protective benefits?

    Yes, the cement functions as a protective barrier for the tooth and is formulated to release fluoride, which is beneficial in clinical dental applications.

  • Who is authorized to use this device?

    This device is intended for application by dental professionals within clinical settings to ensure proper handling and curing of the two-component material.