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NextDent Ortho IBT

by Vertex-Dental B.V. 2 variants

Ref NDOICL01000_2, NDOICL01000_01Model Indirect Bonding Tray Resins, Photo-Cured

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

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/MDR EUDAMED Number871942550NDOIA13S2 Basic UDI-DI Date24 Jul 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08719425509792 UDI-DI Date19 Apr 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
NextDent Ortho IBT EUDAMED
Vertex-Dental BV GUDID
Generic Name
Dental impression tray material
Model / Reference
Indirect Bonding Tray Resins, Photo-Cured, NDOICL01000_2, NDOICL01000_01
Primary DI / UDI-DI
08719425509792, 08720604633931
Basic UDI-DI
871942550NDOIA13S2
FDA Product Code
EBH
EMDN Code
Q0102050199 Dentistry resins - other
GMDN Term
Dental impression tray material
Device Class
Class I
Regulation Number
872.3670
EU market of registration
Austria
Netherlands
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
NL-MF-000019230

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 (20)

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