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Fusio N21SF

by Kerr Corporation

Ref N21SF

Fusio N21SF 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-00814978020980) and listed in FDA GUDID since 1 Aug 2016 (UDI-DI 00814978020980), 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-00814978020980 Basic UDI-DI 00814978020980UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00814978020980 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00814978020980 registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 00814978020980 listed 1 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00814978020980
  2. Registered EUDAMED B-00814978020980

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  • Withdrawn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
Fusio
Generic name
Light-cured dental restorative composite resin
Device name
Fusio Sample Syringe, Shade A2 (Pentron)
Model / reference
N21SF
Description
Self-Adhesive Flowable Composite; Syringe - A2 with 5 x 19 Gauge Bent Needle Tips; Sample
Primary DI / UDI-DI
00814978020980
Basic UDI-DI
B-00814978020980
FDA product code
EBF
EMDN code
Q01010103 Dental restorative composites
GMDN term
Light-cured dental restorative 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
Total Volume — 1 Milliliter

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: Light-cured dental restorative 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
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)