Skip to content

ProBase 170001

by Silmet Ltd

Ref 170001

ProBase 170001 is a device classified as Class IIa in the EU and Class II in the US made by Silmet Ltd, registered in EUDAMED on 30 Jun 2026 (Basic UDI-DI 7290013DMR3XJ) and listed in FDA GUDID since 28 Nov 2016 (UDI-DI 07290015358866), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7290013DMR3XJ Basic UDI-DI 07290015358866UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290015358866 UDI-DI Date28 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7290013DMR3XJ registered 30 Jun 2026 Active
  • FDA GUDID UDI-DI 07290015358866 listed 28 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07290015358866
  2. Registered EUDAMED 7290013DMR3XJ

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  • Withdrawn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
Generic name
Glass ionomer dental cement
Device name
Cements
Model / Ref / Catalog
170001
Primary DI / UDI-DI
07290015358866
Basic UDI-DI
7290013DMR3XJ
FDA product code
EMA
EMDN code
Q01010106 Dental restoration glass ionomers
GMDN term
Glass ionomer dental cement
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3275
EU registration type
Standard device
EU market of registration
Malta
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: Glass ionomer dental cement

Similar devices in this category

Other devices filed under DENTAL RESTORATION GLASS IONOMERS.

Other devices from Silmet Ltd

See all devices from Silmet Ltd →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)