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K-FILES (Nickel-Titanium) 31m/m 35

by DiaDent Group International

Ref PRCCAR40 / 264-S608Model ABSORBENT PAPER POINTS DIA-PRO R #40

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08806383548014 Basic UDI-DI 08806383548014UDI-DIDate31 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806383548014 UDI-DI Date15 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  • Withdrawn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
Coni Di Carta - Paper Points - Absolute Reci EUDAMED
K-FILES (Nickel-Titanium) GUDID
Generic Name
Manual endodontic file/rasp, reusable
Device Name
Absorbent Paper Points
Model / Ref / Catalog
ABSORBENT PAPER POINTS DIA-PRO R #40 EUDAMED
PRCCAR40 / 264-S608 EUDAMED
31m/m 35 GUDID
NT502-307 GUDID
Primary DI / UDI-DI
08806383548014
Basic UDI-DI
B-08806383548014
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 · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
ABSORBENT PAPER POINTS DIA-PRO R #40
PRCCAR40 / 264-S608
GUDID
31m/m 35
Device ClassEUDAMED
Class IIa
GUDID
Class I
SterileEUDAMED
Yes
GUDID
No

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Properties

  • Sterile YesEUDAMEDNoGUDID
  • Prescription Use
  • Premarket Exempt

Other properties (19)

  • Single Use: No
  • Implantable: 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