Meron Dental Cement

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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

Trade Name

Meron

Generic Name

Glass ionomer dental cement

Model / Ref / Catalog

1244, 1090

Description

Glass ionomer luting cement. Low solubility in the mouth. Low acidity. Biocompatible. Easy application.

Primary DI / UDI-DI

E22112441, E22110901

Basic UDI-DI

++E221025000000000096, ++E221024000000000087

510(k) Number

K914612 ↗

FDA Product Code

EMA

EMDN Code

Q0101010201 Dental base cements

GMDN Term

Glass ionomer dental cement

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 872.3275

EU market of registration

Germany

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

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See all devices from VOCO GmbH →

• What types of dental restorations is Meron Dental Cement specifically designed to bond with for permanent use?

  Meron Dental Cement is designed for permanent dental restorations and provides high adhesion to both tooth structures and restorative materials. This ensures durable bonding in clinical applications, making it suitable for luting crowns, bridges, inlays, and other fixed prosthetics where long-term stability is required.

• How is Meron Dental Cement supplied, and what does this mean for handling in a dental office?

  Meron Dental Cement is supplied as a two-part system, meaning it comes in separate components that must be mixed before use. This requires careful handling in the dental office to ensure proper activation and adhesion properties. The single-use nature of the product also means each application should use a fresh, unopened kit to maintain sterility and performance.

• Is Meron Dental Cement intended for reuse, or is it designed for single applications only?

  Meron Dental Cement is explicitly designed for single-use applications. Reusing the cement could compromise its adhesive properties and moisture resistance, potentially leading to clinical failures. Proper handling and adherence to single-use guidelines are essential for achieving long-term stability in dental restorations.

• What regulatory pathways has Meron Dental Cement undergone, and what does this indicate about its approval status?

  Meron Dental Cement has received both FDA 510(k) clearance and MDR (Medical Device Regulation) authorization. The FDA clearance indicates it was determined to be substantially equivalent to a predicate device under the 510(k) review process, while MDR authorization reflects compliance with European Union medical device regulations. These approvals confirm its regulatory standing in both markets.

• How does the moisture and acid resistance of Meron Dental Cement contribute to its clinical performance?

  Meron Dental Cement is formulated with moisture and acid resistance to ensure long-term stability in the oral environment. This property helps prevent degradation of the bond between the cement and dental restorations, reducing the risk of marginal leakage or failure over time. This is particularly important in areas exposed to saliva or acidic foods, where traditional cements might weaken.