Skip to content

Futurabond U 1578

by VOCO GmbH

Ref 1578

Futurabond U 1578 is a device classified as Class IIa in the EU and Class II in the US made by VOCO GmbH, registered in EUDAMED on 11 May 2026 (Basic UDI-DI ++E2210639010000000LL), cleared under FDA 510(k) K130486 on 20 Jun 2013 and listed in FDA GUDID since 4 Dec 2024 (UDI-DI E22115781), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K130486

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E2210639010000000LL Basic UDI-DI E22115781UDI-DIDate11 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE22115781 UDI-DI Date4 Dec 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK130486 Date20 Jun 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++E2210639010000000LL registered 11 May 2026 Active
  • FDA 510(k) K130486 decided 20 Jun 2013 Active
  • FDA GUDID UDI-DI E22115781 listed 4 Dec 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K130486
  2. Listed FDA GUDID E22115781
  3. Registered EUDAMED ++E2210639010000000LL

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Futurabond U bottle DCA EUDAMED
Futurabond U GUDID
Generic name
Dentine bonding agent/set
Device name
Futurabond U bottle
Model / Ref / Catalog
1578
Primary DI / UDI-DI
E22115781
Basic UDI-DI
++E2210639010000000LL
510(k) Number
FDA product code
KLE, EMA
EMDN code
Q01010104 Dental bonding agents
GMDN term
Dentine bonding agent/set
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3200, 872.3275
EU registration type
Standard device
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

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: Dentine bonding agent/set

Cleared under the same submission (K130486)

Similar devices in this category

Other devices filed under DENTAL BONDING AGENTS.

Other devices from VOCO GmbH

See all devices from VOCO GmbH →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)