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Multilink Hybrid Abutment 647182AN

by Ivoclar Vivadent Aktiengesellschaft

Ref 647182AN

Multilink Hybrid Abutment 647182AN is a device classified as Class IIa in the EU and Class II in the US made by Ivoclar Vivadent Aktiengesellschaft, registered in EUDAMED on 18 Jun 2026 (Basic UDI-DI 76152082ACEME003DZ) and listed in FDA GUDID since 22 Aug 2022 (UDI-DI 07615208296273), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76152082ACEME003DZ Basic UDI-DI 07615208296273UDI-DIDate18 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07615208296273 UDI-DI Date22 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 76152082ACEME003DZ registered 18 Jun 2026 Active
  • FDA GUDID UDI-DI 07615208296273 listed 22 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07615208296273
  2. Registered EUDAMED 76152082ACEME003DZ

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  • Withdrawn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
Multilink Hybrid Abutment Refill HO 0 EUDAMED
Multilink Hybrid Abutment GUDID
Generic name
Dental composite resin
Model / Ref / Catalog
647182AN
Primary DI / UDI-DI
07615208296273
Basic UDI-DI
76152082ACEME003DZ
FDA product code
EMA
EMDN code
Q0101010201 Dental base cements
GMDN term
Dental composite resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3275
EU registration type
Standard device
EU 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

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

Related devices

Category: Dental composite resin

Similar devices in this category

Other devices filed under DENTAL BASE CEMENTS.

Other devices from Ivoclar Vivadent Aktiengesellschaft

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Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)