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Dental Root-canal Instruments

by Shenzhen Superline Technology Co., Ltd. 4 variants

Ref AB2460404AModel F1

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06944835173321 Basic UDI-DI 06944835173321UDI-DIDate9 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944835173321 UDI-DI Date20 Feb 2026ListedStatusListed GUDID: not 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  • Withdrawn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
Dia-X File
Generic Name
Rotary/reciprocating endodontic file/rasp, single-use
Device Name
Dental Root-canal Instruments
Model / Ref / Catalog
F1 EUDAMED
AB2460404A EUDAMED
21mm D3 GUDID
571-S103 GUDID
Primary DI / UDI-DI
06944835173321
Basic UDI-DI
B-06944835173321
FDA Product Code
EKS
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
GMDN Term
Rotary/reciprocating endodontic file/rasp, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4565
EU market of registration
Ireland
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
F1
AB2460404A
GUDID
21mm D3
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000027059
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Shenzhen Superline Technology Co., Ltd.

See all devices from Shenzhen Superline Technology Co., Ltd. →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt

Other properties (21)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: 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