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Structur 3 SC

by VOCO GmbH

Ref 2500, 2510, 2517, 2503, 2506, 2505, 2515

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

1 ongoing

Recall on shared 510(k) K040769; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K120779↗

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E2210427000000000EW Basic UDI-DI Date30 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE22125001 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK120779 Date1 Jun 2012IssuedStatusActive

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

1 recall · 1 ongoing · FDA

    • Ongoing Z-3015-2026 FDA Class II initiated 9 Jul 2026 on shared 510(k) K040769

    Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
Structur 3 SC EUDAMED
Structur 3 GUDID
Generic Name
Temporary dental crown/bridge
Model / Ref / Catalog
2500, 2510, 2503, 2517, 2506, 2505, 2515
Description
Self-curing composite material for the fabrication of provisional crowns and bridges. This kit contains a cartrige 50 ml A2, dispenser type 2 and accessories.
Self-curing composite material for the fabrication of provisional crowns and bridges.
Primary DI / UDI-DI
E22125001, E22125101, E22125031, E22125171, E22125061, E22125051, E22125151
Basic UDI-DI
++E2210427000000000EW
510(k) Number
FDA Product Code
EBG
EMDN Code
Q01020605 Temporary dental prostheses
GMDN Term
Temporary dental crown/bridge
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3770
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000008601

Related devices

Category: Temporary dental crown/bridge

Other devices from VOCO GmbH

See all devices from VOCO GmbH →

Properties

  • Prescription Use
  • Convenience Kit YesGUDIDNoGUDID
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No