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Simile N56AX

by Kerr Corporation

Ref N56AX

Simile N56AX is a device classified as Class IIa in the EU and Class II in the US made by Kerr Corporation, registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI B-00841396181344) and listed in FDA GUDID since 4 May 2017 (UDI-DI 00841396181344), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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/MDD EUDAMED NumberB-00841396181344 Basic UDI-DI 00841396181344UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841396181344 UDI-DI Date4 May 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00841396181344 registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 00841396181344 listed 4 May 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841396181344
  2. Registered EUDAMED B-00841396181344

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Simile
Generic name
Dental composite resin
Device name
Simile Nano-Hybrid 4gm Opaque Dark (Pentron)
Model / reference
N56AX
Primary DI / UDI-DI
00841396181344
Basic UDI-DI
B-00841396181344
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
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Weight — 4 Gram

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.

Related devices

Category: Dental composite resin

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

Other devices from Kerr Corporation

See all devices from Kerr Corporation →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)