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MultiMatch Flow Chameleon AntiMicrobial Composite

by Premier Dental Products Company

510(k) K253513

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 NumberK253513 Date7 Nov 2025ClearedStatusActive

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  • Withdrawn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.

MultiMatch Flow Chameleon AntiMicrobial Composite is a dental device classified as substantially equivalent under FDA 510(k) clearance. It is a universal-shade antimicrobial flowable composite formulated with BioArmor™ technology to help reduce bacterial load and demineralization, supporting healthier restorations.

The device is supplied as a flowable composite material for dental restorative use. It is intended for use in dental settings and is authorized under FDA 510(k) with K number K253513 and product code EBF. No information regarding sterility, single-use or reusable status, MRI safety, sizes, or storage conditions is provided in the data.

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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 MultiMatch Flow Chameleon AntiMicrobial Composite used for?

    It is a dental device intended for restorative use as a flowable composite material in dental settings, formulated with BioArmor™ technology to help reduce bacterial load and demineralization, supporting healthier restorations.

  • How is the MultiMatch Flow Chameleon AntiMicrobial Composite supplied?

    The device is supplied as a flowable composite material for dental restorative use, though specific packaging, sizes, or delivery formats are not detailed in the provided data.

  • Is the MultiMatch Flow Chameleon AntiMicrobial Composite sterile or single-use?

    The provided data does not include information regarding sterility, single-use, or reusable status of the device, so these details cannot be confirmed from the available specifications.