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Provitemp, Dentotemp, Totalcem, Dentocem

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K121804

by Itena Clinical

Identifiers

510(k) Number
K121804 FDA 510(k)
FDA Product Code
EMA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3275 FDA 510(k)
Regulation Number
872.3275 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Dental Cement, classified under the nomenclature for restorative materials used in dental procedures. It is designed to bond dental restorations, such as inlays, onlays, and crowns, to tooth structure, providing mechanical retention and sealing to prevent microleakage.

The product is supplied as a powder-liquid system, requiring mixing before use, and is intended for single-use applications in dental settings. It is not sterile as packaged but is intended to be used in a controlled clinical environment. The device is authorized under FDA 510K and MDD regulations, with a classification as Class II. Sizes and specific formulations vary by variant, as indicated by the registration numbers.

Frequently asked questions

What types of dental restorations is this cement designed to bond, and how does it work?

This dental cement is specifically formulated to bond dental restorations such as inlays, onlays, and crowns to tooth structure. It provides mechanical retention and creates a seal to prevent microleakage, ensuring a secure and durable fit for these restorations.

Is this cement pre-sterilized, or does it require preparation before use?

The cement is not sterile as packaged and is intended for single-use in a controlled clinical environment. It is supplied as a powder-liquid system, meaning it must be mixed by the clinician before application.

Are there different sizes or formulations available for this product?

Yes, the product line includes multiple variants (PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM) with varying formulations and registration numbers, indicating different compositions or intended applications within dental restorative procedures.

What regulatory pathways has this product followed for approval?

This dental cement has been authorized under FDA 510K (Abbreviated Clearance) and the MDD (Medical Device Directive) in Europe. It is classified as Class II under FDA regulations, indicating a moderate risk level requiring specific compliance measures.

How should this cement be stored, and is it reusable?

The cement is intended for single-use only and must be stored in a controlled environment as specified by the manufacturer. Since it is not sterile as packaged, it should not be reused or resterilized, as this could compromise its performance and safety.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Itena Clinical

Sources (2)

  • FDA 510(k) K121804 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026