Skip to content

FibreKleer 4x N83CE

by Kerr Corporation

Ref N83CE

FibreKleer 4x N83CE is a device classified as Class IIa in the EU and Class I in the US made by Kerr Corporation, registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI B-10814978022516) and listed in FDA GUDID since 1 Aug 2016 (UDI-DI 10814978022516), 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-10814978022516 Basic UDI-DI 10814978022516UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10814978022516 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10814978022516 registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 10814978022516 listed 1 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10814978022516
  2. Registered EUDAMED B-10814978022516

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  • Withdrawn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
FibreKleer 4x Post EUDAMED
FibreKleer 4x GUDID
Generic name
Root canal post, preformed
Device name
FibreKleer 4X Post Original 1.25mm 30pk (yellow)
Model / reference
N83CE
Primary DI / UDI-DI
10814978022516
Basic UDI-DI
B-10814978022516
FDA product code
ELR
EMDN code
Q010599 Dental instruments, single-use - other
GMDN term
Root canal post, preformed
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3810
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 1.25 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Root canal post, preformed

Similar devices in this category

Other devices filed under DENTAL INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Kerr Corporation

See all devices from Kerr Corporation →

Properties

  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)