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Gutta Percha Points Iso 35

by DiaDent Group International 3 variants

Ref 101-407Model GUTTA PERCHA POINTS ISO #35

Gutta Percha Points Iso 35 (101-407) 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 29 Oct 2026 (Basic UDI-DI B-08806383500838) and listed in FDA GUDID since 10 Apr 2020 (UDI-DI 08806383500838), 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-08806383500838 Basic UDI-DI 08806383500838UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806383500838 UDI-DI Date10 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08806383500838 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 08806383500838 listed 10 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08806383500838
  2. Registered EUDAMED B-08806383500838

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  • Withdrawn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
Gutta Percha Points
Generic name
Natural gutta-percha
Model / Ref / Catalog
GUTTA PERCHA POINTS ISO #35, 101-407, ISO 35
Primary DI / UDI-DI
08806383500838
Basic UDI-DI
B-08806383500838
FDA product code
EKM
EMDN code
Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
GMDN term
Natural gutta-percha
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3850
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
GUTTA PERCHA POINTS ISO #35
101-407
GUDID
ISO 35
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: Natural gutta-percha

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

  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Premarket exempt
Other properties (19, all answered No)