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VisCalor bulk 6063

by VOCO GmbH

Ref 6063

VisCalor bulk 6063 is a device classified as Class IIa in the EU and Class I in the US made by VOCO GmbH, registered in EUDAMED on 9 Jul 2026 (Basic UDI-DI ++E2210487020000000MW) and listed in FDA GUDID since 10 May 2019 (UDI-DI E22160631), 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 Number++E2210487020000000MW Basic UDI-DI E22160631UDI-DIDate9 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE22160631 UDI-DI Date10 May 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++E2210487020000000MW registered 9 Jul 2026 Active
  • FDA GUDID UDI-DI E22160631 listed 10 May 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID E22160631
  2. Registered EUDAMED ++E2210487020000000MW

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  • Withdrawn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
VisCalor bulk
Generic name
Dental composite resin
Model / reference
6063
Primary DI / UDI-DI
E22160631
Basic UDI-DI
++E2210487020000000MW
FDA product code
EFC, EBZ, EBF, EEG
EMDN code
Q01010103 Dental restorative composites
GMDN term
Dental composite resin
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.6100, 872.6070, 872.3690, 872.6475
System or procedure pack
System
EU registration type
System or procedure pack
Medical purpose
Indications: – Class I and II posterior restorations – Base in class I and II cavities – Class V restorations – Locking, splinting of loose teeth – Repairing veneers, enamel defects and temporary C&B-materials – Extended fissure sealing – Restoration of deciduous teeth – Core build-up
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Dental composite resinAnaesthesia warmer

Similar devices

Also classified as Anaesthesia warmer.

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

Other devices from VOCO GmbH

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Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)