Meta P&Bond Silane Ceramic Primer – Dental Adhesion Cement

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-08806387894087 Basic UDI-DI	Date21 May 2026Registered	StatusActive
United States	GUDID listing GUDID	Number08806387894070 UDI-DI	Date30 Aug 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK171449	Date15 May 2018Decided	StatusActive
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK081913	Date5 Sep 2008Cleared	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-08806387894087 — open Devices and search for it
AccessGUDID record UDI-DI 08806387894070
AccessGUDID record UDI-DI 08806387894087
AccessGUDID record UDI-DI 08806387894094
FDA 510(k) database 510(k) number K171449
FDA 510(k) database 510(k) number K081913

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-08806387894087 registered 21 May 2026 Active
FDA 510(k) K171449 decided 15 May 2018 Active· +1 more in the status table
FDA GUDID UDI-DI 08806387894070 listed 30 Aug 2018 Listed

Timeline

4 dated events

5 Sep 2008 Cleared FDA 510(k) K081913
15 May 2018 Cleared FDA 510(k) K171449
30 Aug 2018 Listed FDA GUDID 08806387894070
21 May 2026 Registered EUDAMED B-08806387894087

Coverage

2 jurisdictions

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Withdrawn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: K081913 510(k)
K171449 GUDID
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 registration type: Legacy device (under a directive)
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

Field	EUDAMED	510(k)	GUDID
Model / reference	EUDAMED Metacem OP Metacem TL Metacem B2	510(k) —	GUDID 9407 9408 9409
510(k) Number	EUDAMED —	510(k) K081913	GUDID K171449
Device class	EUDAMED Class IIa	510(k) Class II	GUDID Class II
Implantable	EUDAMED Yes	510(k) —	GUDID No

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Self-Adhesive Resin Cement K073173 23 Jan 2008 FDA record
Tokuyama Bond Force K070215 30 Mar 2007 FDA record
Peak Bond, Model 5133 K063557 12 Dec 2006 FDA record
Clearfil Ceramic Primer K061906 28 Sep 2006 FDA record
Porcelain Primer K061322 2 Jun 2006 FDA record
Biscem Translucent, Biscem Opaque K060701 15 May 2006 FDA record
Cement-It All Purpose, Model N97 K060698 10 May 2006 FDA record
PMP4 Bp Pro Blood Pressure Monitor K060703 4 Apr 2006 FDA record
Paracem Universal Dc K053040 9 Nov 2005 FDA record
Calibra Cement K040906 16 Jun 2004 FDA record

More clearances are cited in the summary than are listed here.

Cited by

Meta P&Bond K180802 29 Aug 2018 FDA record · FDA summary
Metacem K171449 15 May 2018 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

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.

Devices cleared under K081913

6 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K081913
		UDI-DI	Size and differences
Metacem A1 9216 Meta Biomed Co., Ltd.	9216	08806387892168	—	No longer on the market
Metacem A3 9217 Meta Biomed Co., Ltd.	9217	08806387892175	—	No longer on the market
Metacem B2 9218 Meta Biomed Co., Ltd.	9218	08806387892182	—	No longer on the market
Metacem Kit 9215 Meta Biomed Co., Ltd.	9215	08806387892151	—	No longer on the market
Metacem OP 9219 Meta Biomed Co., Ltd.	9219	08806387892199	—	No longer on the market
metacem TL 9220 Meta Biomed Co., Ltd.	9220	08806387892205	—	No longer on the market

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Properties

Implantable YesEUDAMEDNoGUDID
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (18, all answered No)