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CeraSeal

by Meta Biomed Co., Ltd.

510(k) K190503Model CeraSeal 0.5-Box, CeraSeal, CeraSeal 0.5-Pouch

Active European Union and United States. Also listed in GUDID (US).

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) K190503↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08806387894841 Basic UDI-DI Date21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806387894810 UDI-DI Date6 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK190503 Date7 Jun 2019ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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) · GUDID

Trade Name
CeraSeal EUDAMEDGUDID
CeraSeal 0.5-Pouch GUDID
CeraSeal 0.5-BOX GUDID
Generic Name
Endodontic filling/sealing material
Model / Reference
CeraSeal 0.5-Box EUDAMED
CeraSeal EUDAMED
CeraSeal 0.5-Pouch EUDAMED
9481 GUDID
9412 GUDID
9484 GUDID
Primary DI / UDI-DI
08806387894810, 08806387894124, 08806387894841
Basic UDI-DI
B-08806387894841, B-08806387894124, B-08806387894810
510(k) Number
FDA Product Code
KIF
EMDN Code
Q01010202 Root canal filling dental cements
GMDN Term
Endodontic filling/sealing material
Device Class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 872.3820
EU market of registration
Germany
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 3 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
CeraSeal 0.5-Box
CeraSeal
CeraSeal 0.5-Pouch
510(k)
—
GUDID
9481
9412
9484
Device ClassEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II
ImplantableEUDAMED
Yes
510(k)
—
GUDID
No

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 CeraSeal Bioceramic Root Canal Sealer is a calcium silicate-based material designed for use in endodontic procedures. It functions as a root canal filling material, providing a biocompatible seal within the dental pulp chamber and root canals to prevent microbial leakage and promote periapical healing.

Supplied as a pre-mixed syringe in 2g units, the sealer is intended for single-use in dental settings. It achieves radiopacity greater than 8mm Al and sets within 3.5 hours, with a high pH (12.73) that remains stable over time. Authorized under FDA 510K and MDD compliance, it adheres to Class II medical device regulations (Regulation Number 872.3820) and is classified under the Dental specialty.

Other devices from Meta Biomed Co., Ltd.

See all devices from Meta Biomed Co., Ltd. →

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 CeraSeal Bioceramic Root Canal Sealer in dental procedures?

    The CeraSeal Bioceramic Root Canal Sealer is designed specifically for endodontic procedures to fill root canals. It creates a biocompatible seal within the dental pulp chamber and root canals, preventing microbial leakage and supporting periapical healing during root canal treatments.

  • How is the CeraSeal material supplied, and is it intended for single-use?

    The CeraSeal is supplied as a pre-mixed syringe in 2-gram units, which makes it convenient for direct application in dental settings. The manufacturer explicitly states it is intended for single-use only, ensuring sterility and safety for each procedure.

  • What are the key radiopacity and setting characteristics of the CeraSeal material?

    CeraSeal achieves high radiopacity, exceeding 8mm of aluminum equivalent, making it easily visible on X-rays. It sets within 3.5 hours, allowing sufficient working time for clinicians while ensuring stability in the root canal system.

  • Does the CeraSeal material have a high pH, and how does this affect its performance?

    Yes, the CeraSeal material maintains a high pH of 12.73, which remains stable over time. This alkaline environment supports its biocompatibility and contributes to promoting periapical healing by creating a favorable biological response in the treated area.

  • What regulatory pathways has the CeraSeal Bioceramic Root Canal Sealer followed, and under which classification is it authorized?

    The CeraSeal has been authorized through the FDA’s 510(k) pathway (Traditional clearance, Substantially Equivalent) and complies with the Medical Device Directive (MDD). It is classified under Class II medical devices (Regulation Number 872.3820) and falls under the Dental specialty category, adhering to strict regulatory standards for endodontic materials.

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No