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Resin Teeth / DCL / PE 541016

by Ivoclar Vivadent Aktiengesellschaft

Ref 541016

Resin Teeth / DCL / PE 541016 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 2 Mar 2026 (Basic UDI-DI 76152082APROS004VZ) and listed in FDA GUDID since 8 Feb 2023 (UDI-DI 07615208408263), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76152082APROS004VZ Basic UDI-DI 07615208408263UDI-DIDate2 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07615208408263 UDI-DI Date8 Feb 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 76152082APROS004VZ registered 2 Mar 2026 Active
  • FDA GUDID UDI-DI 07615208408263 listed 8 Feb 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07615208408263
  2. Registered EUDAMED 76152082APROS004VZ

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  • Withdrawn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
SR Vivodent Set of 6 LA4 540 EUDAMED
Resin Teeth / DCL / PE GUDID
Generic name
Resin artificial teeth
Device name
Ivostar / Gnathostar, Ivocryl, Resin Teeth / DCL / PE, Resin Teeth S PE / S DCL, SR Phonares II
Model / Ref / Catalog
541016
Primary DI / UDI-DI
07615208408263
Basic UDI-DI
76152082APROS004VZ
FDA product code
ELM
EMDN code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN term
Resin artificial teeth
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3590
EU registration type
Standard device
EU market of registration
Liechtenstein
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Resin artificial teeth

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Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)