Skip to content

Monobond Etch & Prime 673026WW

by Ivoclar Vivadent Aktiengesellschaft

Ref 673026WW

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76152082ABOND008HY Basic UDI-DI 07615208295375UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07615208295375 UDI-DI Date6 Apr 2023ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Monobond Etch & Prime Refill 5g EUDAMED
Monobond Etch & Prime GUDID
Generic Name
Dentine bonding agent/set
Model / Ref / Catalog
673026WW
Primary DI / UDI-DI
07615208295375
Basic UDI-DI
76152082ABOND008HY
FDA Product Code
KLE
EMDN Code
Q01010104 Dental bonding agents
GMDN Term
Dentine bonding agent/set
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3200
Market of Registration
Liechtenstein
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

Related devices

Category: Dentine bonding agent/set

Other devices from Ivoclar Vivadent Aktiengesellschaft

See all devices from Ivoclar Vivadent Aktiengesellschaft →

Properties

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

Other properties (19)

  • 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