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K-FILE.04 TAPER 25m/m 40

by DiaDent Group International

Ref 47919 / 158-S605, 47967 / 258-S605, 47921 / 158-S607, 47924 / 158-S691, 47968 / 258-S606, 47966 / 258-S604, 47923 / 158-S609Model GUTTA PERCHA POINTS DIA-PROISO.04 #25, ABSORBENT PAPER POINTS DIA-PROISO.04 #25, GUTTA PERCHA POINTS DIA-PROISO.04 #35, GUTTA PERCHA POINTS DIA-PROISO.04 #15/40, ABSORBENT PAPER POINTS DIA-PROISO.04 #30, ABSORBENT PAPER POINTS DIA-PROISO.04 #20, GUTTA PERCHA POINTS DIA-PROISO.04 #45

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08806383533676 Basic UDI-DI Date26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806383533676 UDI-DI Date11 Jun 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
.04 Taper EUDAMED
K-FILE.04 Taper GUDID
Generic Name
Manual endodontic file/rasp, reusable
Device Name
Gutta Percha Points
Absorbent Paper Points
Model / Ref / Catalog
GUTTA PERCHA POINTS DIA-PROISO.04 #25 EUDAMED
47919 / 158-S605 EUDAMED
ABSORBENT PAPER POINTS DIA-PROISO.04 #25 EUDAMED
47967 / 258-S605 EUDAMED
GUTTA PERCHA POINTS DIA-PROISO.04 #35 EUDAMED
47921 / 158-S607 EUDAMED
GUTTA PERCHA POINTS DIA-PROISO.04 #15/40 EUDAMED
47924 / 158-S691 EUDAMED
ABSORBENT PAPER POINTS DIA-PROISO.04 #30 EUDAMED
47968 / 258-S606 EUDAMED
ABSORBENT PAPER POINTS DIA-PROISO.04 #20 EUDAMED
47966 / 258-S604 EUDAMED
GUTTA PERCHA POINTS DIA-PROISO.04 #45 EUDAMED
47923 / 158-S609 EUDAMED
25m/m 40 GUDID
NT507-208 GUDID
Primary DI / UDI-DI
08806383533676 EUDAMED
08806383547727 EUDAMED
08806383533690 EUDAMED
08806383533720 EUDAMED
08806383547734 EUDAMED
08806383547710 EUDAMED
08806383533713 EUDAMED
08806383551984 GUDID
Basic UDI-DI
B-08806383533676, B-08806383547727, B-08806383533690, B-08806383533720, B-08806383547734, B-08806383547710, B-08806383533713
FDA Product Code
EKS
EMDN Code
Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
GMDN Term
Manual endodontic file/rasp, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4565
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 5 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
GUTTA PERCHA POINTS DIA-PROISO.04 #25
47919 / 158-S605
ABSORBENT PAPER POINTS DIA-PROISO.04 #25
47967 / 258-S605
GUTTA PERCHA POINTS DIA-PROISO.04 #35
47921 / 158-S607
GUTTA PERCHA POINTS DIA-PROISO.04 #15/40
47924 / 158-S691
ABSORBENT PAPER POINTS DIA-PROISO.04 #30
47968 / 258-S606
ABSORBENT PAPER POINTS DIA-PROISO.04 #20
47966 / 258-S604
GUTTA PERCHA POINTS DIA-PROISO.04 #45
47923 / 158-S609
GUDID
25m/m 40
Primary DI / UDI-DIEUDAMED
08806383533676
08806383547727
08806383533690
08806383533720
08806383547734
08806383547710
08806383533713
GUDID
08806383551984
Device ClassEUDAMED
Class IIa
GUDID
Class I
SterileEUDAMED
No
Yes
GUDID
No
ImplantableEUDAMED
No
Yes
GUDID
No

Related devices

Category: Manual endodontic file/rasp, reusable

Other devices from DiaDent Group International

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Properties

  • Sterile NoEUDAMEDGUDIDYesEUDAMED
  • Implantable NoEUDAMEDGUDIDYesEUDAMED
  • Prescription Use
  • Premarket Exempt

Other properties (18)

  • Single Use: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No