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Absorbent Paper Points Iso 45

by DiaDent Group International 4 variants

Ref 201-S609Model ABSORBENT PAPER POINTS ISO #45

Absorbent Paper Points Iso 45 (201-S609) is a device classified as Class IIa in the EU and Class I in the US made by DiaDent Group International, registered in EUDAMED on 10 Jul 2026 (Basic UDI-DI B-08806383568302) and listed in FDA GUDID since 7 May 2020 (UDI-DI 08806383568302), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08806383568302 Basic UDI-DI 08806383568302UDI-DIDate10 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806383568302 UDI-DI Date7 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08806383568302 registered 10 Jul 2026 Active
  • FDA GUDID UDI-DI 08806383568302 listed 7 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08806383568302
  2. Registered EUDAMED B-08806383568302

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  • Withdrawn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
Absorbent Paper Points
Generic name
Endodontic paper point
Model / Ref / Catalog
ABSORBENT PAPER POINTS ISO #45, 201-S609, ISO 45
Primary DI / UDI-DI
08806383568302
Basic UDI-DI
B-08806383568302
FDA product code
EKN
EMDN code
Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
GMDN term
Endodontic paper point
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3830
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ABSORBENT PAPER POINTS ISO #45
201-S609
GUDID
ISO 45
Device classEUDAMED
Class IIa
GUDID
Class I

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 paper point

Similar devices in this category

Other devices filed under PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY.

Other devices from DiaDent Group International

See all devices from DiaDent Group International →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
Other properties (19, all answered No)