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Metapaste Plus Resin Root Canal Filling

by Meta Biomed Co., Ltd.

510(k) K210904

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210904↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK210904 Date30 Jun 2021ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Metapaste Plus
510(k) Number
FDA Product Code
KIF
Device Class
Class II
Regulation
21 CFR Part 872.3820
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

The Metapaste Plus Resin Root Canal Filling is a dental material classified as a resin-based substance used for filling root canals. It is designed to provide a durable seal within the root canal system, preventing bacterial leakage and supporting long-term periradicular healing during endodontic treatment.

This device is supplied as a single-use, non-sterile paste intended for use in dental offices. It is regulated under FDA 510(k) clearance (K210904) and the Medical Device Directive (MDD), with a classification of Class II (device code 872.3820). The product is distributed in various registration numbers and FEI numbers, adhering to dental specialty standards for root canal procedures.

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Questions

AI-generated answers, 18 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 purpose of the Metapaste Plus Resin Root Canal Filling in dental procedures?

    The Metapaste Plus Resin Root Canal Filling is designed specifically to provide a durable seal within the root canal system during endodontic treatment. Its purpose is to prevent bacterial leakage and support long-term periradicular healing, ensuring the treated area remains protected and stable over time.

  • Is the Metapaste Plus supplied sterile or non-sterile, and how should it be handled in a dental office?

    The Metapaste Plus is supplied as a non-sterile paste, intended for single-use in dental offices. Since it is non-sterile, it should be handled in a clean environment, and standard aseptic techniques should be followed to minimize contamination before use.

  • Are there multiple sizes or models of the Metapaste Plus, and how can I identify the correct registration or FEI number for my region?

    The Metapaste Plus is available in multiple registration numbers and FEI numbers, which vary by region and regulatory requirements. The device is classified under OpenFDA device code 872.3820 and has numerous FEI numbers listed (e.g., 3002807757, 5615, etc.). To ensure compliance, verify the correct registration or FEI number for your country or jurisdiction through official regulatory databases or your local distributor.

  • What regulatory pathways does the Metapaste Plus follow, and how does this affect its availability?

    The Metapaste Plus has received FDA 510(k) clearance (K210904) under the Traditional clearance type, with a decision classified as *Substantially Equivalent* by the Dental (DE) Advisory Committee. It also complies with the Medical Device Directive (MDD) in Europe. These regulatory pathways confirm its market authorization in the U.S. and EU, ensuring its availability for dental professionals in those regions under the specified classifications.