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Argion Dental Cement

by VOCO GmbH

510(k) K926492

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 NumberK926492 Date8 Apr 1993ClearedStatusActive

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  • Withdrawn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, 19 Sep 2026

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

Argion Dental Cement is a dental adhesive restorative material classified as a cement, dental (product code EMA). It is designed for use in dental restorations, providing a durable bond between tooth structures and restorative materials such as inlays, onlays, or core builds. This material is intended to fill gaps and stabilize dental preparations, ensuring long-term retention and mechanical integrity in restorative procedures.

The cement is supplied as a reusable, multi-use product for clinical settings and is regulated under FDA 510(k) clearance (K926492) as a Class II device under 21 CFR 872.3275. It is intended for professional dental use only and requires proper handling and storage as specified by the manufacturer. No additional regulatory markings (e.g., MRI safety, sterility classifications) are indicated in the available data.

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Questions

AI-generated answers, 19 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 Argion Dental Cement primarily used for in dental procedures?

    Argion Dental Cement is designed to bond and stabilize dental restorations, such as inlays, onlays, or core builds, by filling gaps and ensuring long-term retention between tooth structures and restorative materials. It helps maintain mechanical integrity during restorative procedures, providing a durable adhesive solution for professional dental use.

  • Is Argion Dental Cement intended for single-use or multi-use in a clinical setting?

    Argion Dental Cement is supplied as a reusable, multi-use product for clinical settings. This means it can be used multiple times within a professional dental practice, provided proper handling and storage guidelines are followed.

  • How is Argion Dental Cement regulated, and what does that mean for its use?

    Argion Dental Cement is regulated under FDA 510(k) clearance (K926492) as a Class II device under 21 CFR 872.3275, meaning it has been deemed substantially equivalent to a predicate device and meets specific performance standards. This classification ensures it is intended for professional dental use only and requires adherence to manufacturer guidelines for safe and effective application.

  • Are there any specific storage requirements mentioned for Argion Dental Cement?

    The data provided does not explicitly detail storage conditions, but as a reusable, multi-use dental adhesive, it should be stored according to the manufacturer’s instructions to maintain its integrity and effectiveness. Proper handling, such as keeping it in a clean, sealed environment and avoiding contamination, is critical for clinical use.