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Diaplus Universal

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K213401

by Diadent Group International

Identifiers

510(k) Number
K213401 FDA 510(k)
FDA Product Code
KLE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3200 FDA 510(k)
Regulation Number
872.3200 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Diaplus Universal is a Tooth Bonding Resin Agent, classified under FDA product code KLE and regulation 872.3200. This device is designed for dental applications, specifically to bond resin materials to tooth surfaces, facilitating restorative procedures such as fillings, crowns, or other adhesive treatments. It falls under the Medical Specialty Description of Dental and is intended for use in clinical settings where precise bonding is required for dental restoration.

Supplied as a single-use dental resin agent, the Diaplus Universal is intended for professional use by dental practitioners. It is not reusable and must be handled in accordance with standard dental sterilization protocols. The device is not MRI-safe and requires proper storage in a controlled environment to maintain its integrity. Authorized under FDA 510K clearance (K213401), MDD, and MDR, it adheres to regulatory standards for dental adhesives and bonding agents.

Frequently asked questions

What clinical procedures is the Diaplus Universal designed to support in dental restorations?

The Diaplus Universal is specifically designed for bonding resin materials to tooth surfaces, enabling precise adhesion during restorative procedures such as fillings, crowns, or other adhesive treatments in dental restorations. It ensures a strong bond between the resin and tooth structure, which is critical for long-term durability and stability of the restoration.

Is the Diaplus Universal intended for single-use or can it be reused after sterilization?

The Diaplus Universal is explicitly supplied as a single-use dental resin agent. While it is not reusable, it must be handled in compliance with standard dental sterilization protocols for related instruments or materials during use. This ensures safety and maintains the integrity of the bonding process.

What storage conditions are required to maintain the effectiveness of the Diaplus Universal?

The Diaplus Universal must be stored in a controlled environment to preserve its integrity. Since it is not MRI-safe, it should also be kept away from magnetic fields. Proper storage conditions are essential to ensure the resin agent remains effective for its intended clinical use.

What regulatory pathways has the Diaplus Universal undergone to gain market authorization?

The Diaplus Universal has been authorized through FDA 510K clearance (K213401), as well as compliance with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). These pathways confirm its adherence to regulatory standards for dental adhesives and bonding agents, ensuring safety and performance for professional dental use.

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

MDR

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Diadent Group International

Sources (2)

  • FDA 510(k) K213401 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026