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Dytract Flow Restorative

by Dentsply Intl.

510(k) K982395

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 NumberK982395 Date18 Aug 1998ClearedStatusActive

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  • Withdrawn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, 26 Sep 2026

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

DYTRACT FLOW RESTORATIVE is a one-component, low-viscosity, visible light-cured dental composite material. It is radiopaque and fluoride-releasing, designed for use in dental restorative procedures.

It is used by dentists in clinical settings for Class I, III, and V restorations, cavity lining, and repair of dental defects or temporaries. The device is supplied as a material for direct application to tooth structure or restoration site and is classified under product code EBF with FDA 510(k) clearance K982395.

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Questions

AI-generated answers, 26 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 DYTRACT FLOW RESTORATIVE used for?

    DYTRACT FLOW RESTORATIVE is used by dentists in clinical settings for Class I, III, and V restorations, cavity lining, and repair of dental defects or temporaries. It is designed for direct application to tooth structure or restoration sites as a restorative material.

  • How is DYTRACT FLOW RESTORATIVE supplied and applied?

    DYTRACT FLOW RESTORATIVE is supplied as a one-component, low-viscosity material for direct application to tooth structure or restoration sites. It is a visible light-cured composite that requires curing with a dental curing light after placement.

  • Is DYTRACT FLOW RESTORATIVE radiopaque and does it release fluoride?

    Yes, DYTRACT FLOW RESTORATIVE is radiopaque, which allows it to be visible on dental radiographs, and it is fluoride-releasing, providing ongoing fluoride release to help prevent secondary caries around the restoration.