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Rotation Wedges - Clear

by DB Orthodontics Limited

Ref DB03-0001Model Colour Boutique Rotation Wedges

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50560910RotationWedgeC7 Basic UDI-DI 05060429401500UDI-DIDate5 Aug 2026RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Colour Boutique Rotation Wedges
Model / Reference
Colour Boutique Rotation Wedges, DB03-0001
Primary DI / UDI-DI
05060429401500
Basic UDI-DI
50560910RotationWedgeC7
EMDN Code
Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
GB-MF-000023271
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from D B Orthodontics, Ltd.

See all devices from D B Orthodontics, Ltd. →

Properties

Other properties (13)

  • 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