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Duo-Pen Regular Kit

by DiaDent Group International

Ref 4007-2002Model REGULAR KIT

Duo-Pen Regular Kit (4007-2002) is an endodontic obturation system (EU MDD Class IIa; FDA Class I; FDA product code EKR, Plugger, Root Canal, Endodontic) made by DiaDent Group International, registered in EUDAMED on 21 May 2026 (Basic UDI-DI B-08806383557320) and listed in FDA GUDID since 26 May 2020 (UDI-DI 08806383557320), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08806383557320 Basic UDI-DI 08806383557320UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806383557320 UDI-DI Date26 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08806383557320 registered 21 May 2026 Active
  • FDA GUDID UDI-DI 08806383557320 listed 26 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08806383557320
  2. Registered EUDAMED B-08806383557320

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  • Withdrawn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
Duo-Pen
Generic name
Endodontic obturation system
Model / Ref / Catalog
REGULAR KIT, 4007-2002, DUO-PEN REGULAR KIT
Primary DI / UDI-DI
08806383557320
Basic UDI-DI
B-08806383557320
FDA product code
EKR
EMDN code
Q01010299 Root canal filling devices - other
GMDN term
Endodontic obturation system
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4565
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
REGULAR KIT
4007-2002
GUDID
DUO-PEN REGULAR KIT
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 08806383557320: EUDAMED states Yes, FDA GUDID states 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: Endodontic obturation system

Similar devices in this category

Other devices filed under ROOT CANAL FILLING DEVICES - OTHER.

Other devices from DiaDent Group International

See all devices from DiaDent Group International →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Premarket exempt
Other properties (20, all answered No)