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WaveOne® Gold Orifice Shaper Endodontic Reciprocating Files

by Maillefer Instruments Holding Sàrl EUDAMED

Active European Union

Ref BSTW1G1316OSHModel WaveOne Gold (SU, NiTi, Ro, MSA)

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++J00310039E8 Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
WaveOne® Gold
Model / Reference
WaveOne Gold (SU, NiTi, Ro, MSA), BSTW1G1316OSH
Primary DI / UDI-DI
J003BSTW1G1316OSH1
Basic UDI-DI
++J00310039E8
Unit of Use DI
J003BSTW1G1316OSH0
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class IIa
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CH-MF-000016301
Authorised representative
Dentsply DeTrey GmbH DE-AR-000005904

Other devices from Maillefer Instruments Holding Sàrl

See all devices from Maillefer Instruments Holding Sàrl →

Properties

  • Sterile

Other properties (12)

  • 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