Skip to content

ProBase Hot / ProBase Cold 578940

by Ivoclar Vivadent Aktiengesellschaft

Part of a family of 74 devices: see the family page

Ref 578940

ProBase Hot / ProBase Cold 578940 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 8 Jun 2026 (Basic UDI-DI 76152082APROS001VT) and listed in FDA GUDID since 22 Aug 2022 (UDI-DI 07615208386660), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76152082APROS001VT Basic UDI-DI 07615208386660UDI-DIDate8 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07615208386660 UDI-DI Date22 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 76152082APROS001VT registered 8 Jun 2026 Active
  • FDA GUDID UDI-DI 07615208386660 listed 22 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07615208386660
  2. Registered EUDAMED 76152082APROS001VT

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  • Withdrawn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
ProBase Cold Polymer 20x500 g Preference EUDAMED
ProBase Hot / ProBase Cold GUDID
Generic name
Dental appliance fabrication material, resin
Device name
ProBase Hot / ProBase Cold, SR Triplex Cold
Model / Ref / Catalog
578940
Primary DI / UDI-DI
07615208386660
Basic UDI-DI
76152082APROS001VT
Unit of use DI
07615208433302
FDA product code
EBI
EMDN code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN term
Dental appliance fabrication material, resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3760
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

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: Dental appliance fabrication material, resin

Similar devices in this category

Other devices filed under MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER.

Other devices from Ivoclar Vivadent Aktiengesellschaft

See all devices from Ivoclar Vivadent Aktiengesellschaft →

Properties

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