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UniCore 4096

by Ultradent Products, Inc.

Ref 4096

UniCore 4096 is a device classified as Class IIa in the EU and Class I in the US made by Ultradent Products, Inc., registered in EUDAMED on 29 May 2026 (Basic UDI-DI 0883205-TF119B5) and listed in FDA GUDID since 7 Feb 2018 (UDI-DI 00883205004628), 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 Number0883205-TF119B5 Basic UDI-DI 00883205004628UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205004628 UDI-DI Date7 Feb 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0883205-TF119B5 registered 29 May 2026 Active
  • FDA GUDID UDI-DI 00883205004628 listed 7 Feb 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00883205004628
  2. Registered EUDAMED 0883205-TF119B5

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  • Withdrawn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
UniCore Post System Size 1 EUDAMED
UniCore GUDID
Generic name
Root canal post, preformed
Device name
Unicore Post
Model / Ref / Catalog
4096
Primary DI / UDI-DI
00883205004628
Basic UDI-DI
0883205-TF119B5
FDA product code
ELR
EMDN code
Q010199 Conservative dentistry and endodontics devices - other
GMDN term
Root canal post, preformed
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3810
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

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 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER.

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)