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Meta P&Bond Silane Ceramic Primer

by Meta Biomed Co., Ltd.

510(k) K081913Model Metacem OP, Metacem TL, Metacem B2

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) K081913↗

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-08806387894087 Basic UDI-DI Date21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806387894070 UDI-DI Date30 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK081913 Date5 Sep 2008ClearedStatusActive

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  • Withdrawn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
Metacem, Meta P&Bond, Metacem Silane Ceramic Primer
Trade Name
Metacem EUDAMED
Metacem B2 GUDID
Metacem OP GUDID
Metacem TL GUDID
Generic Name
Dental composite resin
Device Name
Dual Cure Adhesive Resin Cement
Model / Reference
Metacem OP EUDAMED
Metacem TL EUDAMED
Metacem B2 EUDAMED
9407 GUDID
9408 GUDID
9409 GUDID
Primary DI / UDI-DI
08806387894070, 08806387894087, 08806387894094
Basic UDI-DI
B-08806387894087, B-08806387894094, B-08806387894070
510(k) Number
FDA Product Code
EMA
EMDN Code
Q0101010299 Temporary and permanent dental restoration cements - other
GMDN Term
Dental composite resin
Device Class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 872.3275
EU market of registration
Germany
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 4 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
Metacem OP
Metacem TL
Metacem B2
510(k)
—
GUDID
9407
9408
9409
510(k) NumberEUDAMED
—
510(k)
K081913
GUDID
K171449
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 Meta P&Bond Silane Ceramic Primer is a dental cement primer designed to enhance adhesion between ceramic restorations and dental adhesive systems. Classified as a Cement, Dental, it serves as a bonding agent to improve the mechanical retention of ceramic veneers, crowns, and inlays by promoting a strong bond with resin-based cements or bonding agents.

This single-use, liquid primer is supplied in sterile, pre-filled bottles and is intended for use in dental clinics or laboratories. It is classified as a Class II device under the FDA and adheres to the Medical Device Directive (MDD) in the EU. The primer requires no special storage conditions beyond protection from extreme temperatures and light, and its use is regulated under the FDA regulation number 872.3275 and OpenFDA product codes for dental cements.

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 Meta P&Bond Silane Ceramic Primer in dental procedures?

    The Meta P&Bond Silane Ceramic Primer is specifically designed to enhance adhesion between ceramic restorations—such as veneers, crowns, and inlays—and dental adhesive systems. It acts as a bonding agent to improve mechanical retention, ensuring a stronger bond with resin-based cements or bonding agents, which helps prevent premature failure of ceramic restorations.

  • How is the Meta P&Bond Silane Ceramic Primer supplied, and is it reusable?

    The primer is supplied as a single-use, liquid formulation in sterile, pre-filled bottles, making it convenient for use in dental clinics or laboratories. Since it is explicitly labeled as single-use, it should not be reused to maintain sterility and performance.

  • Are there any special storage requirements for the Meta P&Bond Silane Ceramic Primer?

    No special storage conditions are required beyond protecting the primer from extreme temperatures and light. It should be stored in a way that preserves its integrity until use, ensuring it remains effective for its intended purpose.

  • What regulatory pathways has the Meta P&Bond Silane Ceramic Primer followed, and where is it authorized?

    The primer has been authorized through the FDA’s 510(k) clearance process, demonstrating it is classified as substantially equivalent to a predicate device. It also complies with the Medical Device Directive (MDD) in the EU, indicating its regulatory approval in both markets. The device is categorized under FDA regulation number 872.3275 and OpenFDA product codes for dental cements.

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