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ProFil 184B01

by Silmet Ltd

Ref 184B01

ProFil 184B01 is a device classified as Class IIa in the EU and Class II in the US made by Silmet Ltd, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 7290012DMR2X5) and listed in FDA GUDID since 21 Nov 2016 (UDI-DI 07290015358132), 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 Number7290012DMR2X5 Basic UDI-DI 07290015358132UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290015358132 UDI-DI Date21 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7290012DMR2X5 registered 28 May 2026 Active
  • FDA GUDID UDI-DI 07290015358132 listed 21 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07290015358132
  2. Registered EUDAMED 7290012DMR2X5

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  • Withdrawn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
ProFil
Generic name
Dental composite resin
Device name
Composites
Model / Ref / Catalog
184B01
Primary DI / UDI-DI
07290015358132
Basic UDI-DI
7290012DMR2X5
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
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Dental composite resin

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)