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Nuance FLOW

by Den-Mat Holdings, LLC

510(k) K143679

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 NumberK143679 Date1 May 2015ClearedStatusActive

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  • Withdrawn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
EBF
Device class
Class II
Regulation
21 CFR Part 872.3690
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

Nuance Flow is a light-cured flowable composite resin intended for use in anterior or posterior restorations. The material features a self-leveling viscosity designed to facilitate placement in the pulpal or axial layers of posterior restorations without running or dripping.

This device is supplied in a syringe and is radiopaque. It is authorized via FDA 510K clearance under K143679. Users are advised not to mix this product with other competitor composite resins to avoid the risk of a failed restoration.

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Questions

AI-generated answers, 24 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 the primary clinical application for Nuance FLOW?

    Nuance FLOW is a light-cured flowable composite resin designed for use in both anterior and posterior dental restorations. Its self-leveling viscosity is specifically engineered to allow for easy placement in the pulpal or axial layers of posterior restorations while maintaining control to prevent running or dripping.

  • How is the Nuance FLOW material supplied?

    This device is supplied in a syringe format, which is designed to facilitate the precise application of the material during restorative procedures.

  • Can Nuance FLOW be mixed with other composite resins?

    No, users are advised not to mix Nuance FLOW with other competitor composite resins. Combining different materials may compromise the integrity of the chemical composition and increase the risk of a failed restoration.

  • Is Nuance FLOW radiopaque?

    Yes, Nuance FLOW is a radiopaque material. This property is important in dental restorations as it allows the material to be visible on X-ray images, assisting clinicians in evaluating the restoration after placement.

  • What is the regulatory status of this device?

    Nuance FLOW has received FDA 510K clearance under K143679. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.