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Estelite Flow Quick

by Tokuyama Dental Corporation

510(k) K051808

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 NumberK051808 Date8 Aug 2005ClearedStatusActive

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  • Withdrawn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, 21 Sep 2026

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

Estelite Flow Quick is a dental composite material used for restorative procedures. It is designed for easy handling and placement in dental applications.

This device is supplied as a single-use product and is not MRI compatible. It is stored at room temperature and has received FDA 510(k) clearance with the product code EBF.

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Questions

AI-generated answers, 21 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 Estelite Flow Quick used for?

    Estelite Flow Quick is a dental composite material designed for restorative procedures, offering easy handling and placement in dental applications.

  • How is Estelite Flow Quick supplied?

    Estelite Flow Quick is supplied as a single-use product, meaning it should be discarded after one use to ensure patient safety and product integrity.

  • What are the storage requirements for Estelite Flow Quick?

    Estelite Flow Quick should be stored at room temperature to maintain its stability and effectiveness until use.

  • Is Estelite Flow Quick MRI compatible?

    No, Estelite Flow Quick is not MRI compatible, so it should not be used in patients undergoing MRI procedures.

  • What regulatory approval has Estelite Flow Quick received?

    Estelite Flow Quick has received FDA 510(k) clearance with the product code EBF, indicating it is substantially equivalent to other legally marketed devices.