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Mynol® Gutta Percha Points

by Sure Dent Corporation 29 variants

Ref MY-01205

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880926429GP2D Basic UDI-DI 08800069203037UDI-DIDate7 Mar 2025RegisteredStatusActive

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  • Withdrawn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
Gutta Percha Points
Model / Reference
MY-01205
Primary DI / UDI-DI
08800069203037
Basic UDI-DI
880926429GP2D
Direct Marketing DI
08800069203037
EMDN Code
Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000018662
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Sure Dent Corporation

See all devices from Sure Dent Corporation →

Properties

  • Implantable

Other properties (12)

  • Sterile: 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