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Sapphire Plus Bracket MBT .018" LR Cuspid With Hook Torq. -6° Ang. +3°

by Modern Orthodontics

Ref BTS-M8-520

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 Number89043763BracketsNK Basic UDI-DI 89043763037538UDI-DIDate27 May 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  • Withdrawn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
Orthodontic Bracket
Model / Reference
BTS-M8-520
Primary DI / UDI-DI
89043763037538
Basic UDI-DI
89043763BracketsNK
EMDN Code
Q010403 Orthodontic brackets and buttons
Device Class
Class IIa
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
IN-MF-000009197
Authorised representative
Internacional Ventur S.A. ES-AR-000001074

From the manufacturer

Manufacturer's product page: Sapphire Plus Low-profile

Other devices from Modern Orthodontics

See all devices from Modern Orthodontics →

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