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VisCalor bulk

by VOCO GmbH

Ref 6064, 6065, 6068

VisCalor bulk (6064) is a device classified as Class IIa in the EU and Class II in the US made by VOCO GmbH, registered in EUDAMED on 30 Mar 2026 (Basic UDI-DI ++E2210487000000000LQ), cleared under FDA 510(k) K201307 on 8 Jul 2020 (1 earlier submission) and listed in FDA GUDID since 1 May 2019 (UDI-DI E22160641), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201307↗

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E2210487000000000LQ Basic UDI-DI Date30 Mar 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK201307 Date8 Jul 2020IssuedStatusActive
United StatesGUDID listing GUDID NumberE22160641 UDI-DI Date1 May 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++E2210487000000000LQ registered 30 Mar 2026 Active
  • FDA 510(k) K201307 decided 8 Jul 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI E22160641 listed 1 May 2019 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K190453
  2. Listed FDA GUDID E22160641
  3. Cleared FDA 510(k) K201307
  4. Registered EUDAMED ++E2210487000000000LQ

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  • Withdrawn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

Generic name
Dental composite resin
Model / reference
6064, 6065, 6068
Primary DI / UDI-DI
E22160641, E22160651, E22160681
Basic UDI-DI
++E2210487000000000LQ
510(k) Number
FDA product code
EBF
EMDN code
Q01010103 Dental restorative composites
GMDN term
Dental composite resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690
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.

Manufacturer details

EUDAMED SRN
DE-MF-000008601

Related devices

Category: Dental composite resin

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

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)