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Fusion Self Etch

by Prevest Denpro Limited India EUDAMED

Ref 10001-1Model Adhesives

EMDN Q01010104

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-+D9671000110- Basic UDI-DIDate18 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Adhesives, 10001-1
Primary DI / UDI-DI
+D9671000110-
Basic UDI-DI
B-+D9671000110-
EMDN Code
Q01010104 Dental bonding agents
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IN-MF-000011546
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Prevest Denpro Limited

See all devices from Prevest Denpro Limited →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED +D9671000110-|B-+D9671000110- 61 fields · synced 24 Oct 2026