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Orthodontic Metal Brackets

by Creative Dental 717 variants

Ref Thomas M, Self ligating, high torque 0.022" UR5Model self-Ligating bracket ROTH（0.018"、0.022"）

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 Number697443505MR012G3 Basic UDI-DI 06942665507798UDI-DIDate31 Jul 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  • Withdrawn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

Model / Reference
self-Ligating bracket ROTH（0.018"、0.022"）, Thomas M, Self ligating, high torque 0.022" UR5
Primary DI / UDI-DI
06942665507798
Basic UDI-DI
697443505MR012G3
EMDN Code
Q010403 Orthodontic brackets and buttons
Device Class
Class IIa
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000025975
Authorised representative
Prolinx GmbH DE-AR-000005129

Other devices from Creative Dental

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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