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Meron Plus QM

by VOCO GmbH

Ref 1727, 1728, 1731Model powder

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

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180386↗

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E2210256000000000EL Basic UDI-DI Date30 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE22117271 UDI-DI Date14 May 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK180386 Date8 May 2018IssuedStatusActive

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 25 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Meron Plus QM
Meron Plus
Generic Name
Glass ionomer dental cement
Dental composite resin
Model / Ref / Catalog
1727, 1728, 1731, powder
Description
resin-reinforced glass ionomer luting cement
Resin reinforced glass ionomer luting cement. Powder 15 g.
Primary DI / UDI-DI
E22117271, E22117281, E22117311
Basic UDI-DI
++E2210256000000000EL, B-E22117311
FDA Product Code
EMA
EMDN Code
Q0101010201, Q0101010299
GMDN Term
Glass ionomer dental cement
Dental composite resin
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3275
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
DE-MF-000008601

Related devices

Category: Dental composite resin

Other devices from VOCO GmbH

See all devices from VOCO GmbH →

Properties

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

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: 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
  • Manufacturing Date: No