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ADSEAL Plus Resin Root Canal Filling

by Meta Biomed Co., Ltd.

510(k) K230010Model ADSEAL Plus Auto-Mix, ADSEAL Plus

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) K230010↗

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-08806387894780 Basic UDI-DI Date20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806387894773 UDI-DI Date24 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK230010 Date13 Apr 2023ClearedStatusActive

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  • Withdrawn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

Full name
ADSEAL Plus
Trade Name
ADSEAL Plus EUDAMEDGUDID
ADSEAL Plus Auto-Mix GUDID
Generic Name
Dental epoxy resin
Model / Reference
ADSEAL Plus Auto-Mix EUDAMED
ADSEAL Plus EUDAMED
9477 GUDID
9478 GUDID
Primary DI / UDI-DI
08806387894773, 08806387894780
Basic UDI-DI
B-08806387894780, B-08806387894773
510(k) Number
FDA Product Code
KIF
EMDN Code
Q01010202 Root canal filling dental cements
GMDN Term
Dental epoxy resin
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
ADSEAL Plus Auto-Mix
ADSEAL Plus
510(k)
—
GUDID
9477
9478
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 ADSEAL Plus is a Resin, Root Canal Filling device, classified as a Class II medical product under FDA regulations. It is designed for use in endodontic procedures to seal the root canal system, providing a durable and biocompatible filling material to prevent microbial leakage and restore tooth integrity.

Supplied as a single-use, non-sterile kit, the ADSEAL Plus is intended for use in dental offices and clinics. It requires no special storage conditions beyond protection from extreme temperatures and moisture. The device holds FDA 510(k) clearance and MDD compliance, adhering to regulatory standards for dental materials. No MRI safety information or reusable components are specified.

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 ADSEAL Plus used for in endodontic procedures?

    The ADSEAL Plus is designed specifically for root canal filling during endodontic treatments. It provides a durable, biocompatible resin material to seal the root canal system, preventing microbial leakage and helping to restore the structural integrity of the tooth. This ensures long-term protection and functionality after the procedure.

  • Is the ADSEAL Plus kit sterile when supplied, and how should it be stored?

    The ADSEAL Plus is supplied as a non-sterile single-use kit, meaning it requires sterilization by the user before use in a clinical setting. Storage only requires protection from extreme temperatures and moisture—no special conditions are needed. Always follow standard dental office protocols for sterilization and handling.

  • Can the ADSEAL Plus be reused, or is it intended for single-use only?

    The ADSEAL Plus is explicitly designed for single-use only. It is supplied as a kit without any reusable components, and reuse is not recommended or supported by the manufacturer. Each kit should be discarded after one use to maintain safety and efficacy.

  • What regulatory approvals does the ADSEAL Plus hold, and how does it meet compliance standards?

    The ADSEAL Plus holds FDA 510(k) clearance and complies with the MDD (Medical Device Directive). It is classified as a Class II medical device under FDA regulations and has been determined *substantially equivalent* to predicate devices in the dental category. This ensures it meets established safety and performance standards for root canal filling materials.

  • Are there different sizes or models of the ADSEAL Plus, and how do I determine the right one for my patient?

    The provided data does not specify distinct sizes or models for the ADSEAL Plus, but it is designed as a universal resin root canal filling system for general endodontic use. Selection typically depends on clinical judgment and the specific anatomy of the root canal system. Consult the manufacturer’s instructions or a dental specialist if unsure, as variations in tooth morphology may influence material selection.

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