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MultiCore HB; MultiCore Flow

by Ivoclar Vivadent, Inc.

510(k) K040795

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 NumberK040795 Date17 May 2004ClearedStatusActive

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  • Withdrawn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
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

MultiCore HB and MultiCore Flow are composite core build-up materials used for the reconstruction of vital and non-vital teeth with part or most of the clinical crown missing. MultiCore HB is designed for the moulding technique while MultiCore Flow is formulated for the matrix technique and can also be used for cementation of endodontic posts due to its low viscosity.

These materials are self-curing with an optional light-curing feature and are available in four shades. The product is supplied as a two-component system and should be stored according to the manufacturer's instructions. The device has FDA 510(k) clearance with product code EBF and was reviewed by the Dental advisory committee.

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Questions

AI-generated answers, 19 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 are MultiCore HB and MultiCore Flow used for?

    MultiCore HB and MultiCore Flow are composite core build-up materials used for reconstructing vital and non-vital teeth with part or most of the clinical crown missing.

  • What is the difference between MultiCore HB and MultiCore Flow?

    MultiCore HB is designed for the moulding technique while MultiCore Flow is formulated for the matrix technique and can also be used for cementation of endodontic posts due to its low viscosity.

  • How are these materials supplied and stored?

    The product is supplied as a two-component system and should be stored according to the manufacturer's instructions.

  • How many shades are available for these materials?

    MultiCore HB and MultiCore Flow are available in four shades.

  • What is the curing mechanism for these materials?

    These materials are self-curing with an optional light-curing feature.