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Vertex-Dental BV NDORBL01000_01

by Vertex-Dental B.V.

Ref NDORBL01000_01

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08720604633894 Basic UDI-DI 08720604633894UDI-DIDate8 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08720604633894 UDI-DI Date19 Apr 2024ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
NextDent EUDAMED
Vertex-Dental BV GUDID
Generic Name
Removable dental occlusal splint, custom-made
Device Name
NextDent Ortho Rigid
Model / Reference
NDORBL01000_01
Primary DI / UDI-DI
08720604633894
Basic UDI-DI
B-08720604633894
FDA Product Code
DYT
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Removable dental occlusal splint, custom-made
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.5525
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Other devices from Vertex-Dental B.V.

See all devices from Vertex-Dental B.V. →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No