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Mosaic Universal Composite

by Ultradent Products, Inc.

510(k) K151094

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K151094↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK151094 Date21 Jul 2015ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
EBF
Device class
Class II
Regulation
21 CFR Part 872.3690
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

The Mosaic Universal Composite is a dental restorative material classified as a Composite Resin for Dental Restoration (FDA Product Code: EBF). It is designed to fill cavities, repair dental defects, and restore the natural appearance and function of teeth by bonding directly to tooth structure. Its universal formulation allows for versatile use across multiple dental applications, including anterior and posterior restorations.

This composite is supplied as a dual-cure system, requiring activation by visible light or chemical curing agents. It is intended for single-use per application and must be handled under aseptic conditions to prevent contamination. The device is regulated under FDA 510K clearance and MDR, with compliance verified through traditional review processes. Storage instructions specify protection from moisture and extreme temperatures, and the product is packaged in sterile, individual units for clinical use.

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Questions

AI-generated answers, 18 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 types of dental restorations can the Mosaic Universal Composite be used for, and why is it called 'universal'?

    The Mosaic Universal Composite is designed for both anterior (front) and posterior (back) dental restorations, including filling cavities and repairing dental defects. It’s called 'universal' because its formulation is versatile enough to be used across a wide range of clinical applications, allowing dentists to restore teeth with a single material for improved convenience and consistency.

  • Is the Mosaic Universal Composite meant for reuse, or is it single-use per application? How does this affect clinical workflow?

    The Mosaic Universal Composite is intended for single-use per application to ensure sterility and prevent cross-contamination. This means each unit is pre-packaged in sterile form and must be discarded after one use. Clinicians should handle it under aseptic conditions, which simplifies workflow by eliminating the need for cleaning or reprocessing between patients.

  • How should the Mosaic Universal Composite be stored, and what precautions should be taken to maintain its integrity?

    The product must be stored protected from moisture and extreme temperatures to preserve its performance. Since it’s supplied in sterile, individual units, clinicians should keep the packaging intact until use. Exposure to humidity or temperature fluctuations could compromise the material’s curing properties or sterility, so adherence to these storage guidelines is critical for reliable results.

  • What curing method does the Mosaic Universal Composite require, and how does this impact its clinical versatility?

    The Mosaic Universal Composite is a dual-cure system, meaning it can be activated by either visible light or chemical curing agents. This dual capability enhances its versatility, as clinicians can choose the method that best fits their practice—whether they prefer light-curing for precision or chemical curing for areas where light may not reach effectively.

  • How does the regulatory pathway for the Mosaic Universal Composite affect its availability or use in clinical settings?

    The device has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) compliance, confirming its safety and effectiveness through traditional review processes. This means it is legally authorized for use in the U.S. and EU markets, respectively, under the specified indications. Clinicians can rely on its regulatory approval as evidence of its clinical suitability for dental restorations.