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Ceramill Ortho IBT

by Vertex-Dental B.V.

Ref 8719425508795Model 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number871942550NDOIA13S2 Basic UDI-DI 08719425508795UDI-DIDate24 Jul 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08719425508795 UDI-DI Date12 Feb 2019ListedStatusListed 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  • Withdrawn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
Ceramill Ortho IBT EUDAMED
Ceramill GUDID
Generic Name
Dental impression tray material
Model / Reference
Indirect Bonding Tray Resins EUDAMED
Photo-Cured EUDAMED
8719425508795 EUDAMED
NPAGOICL01000 GUDID
Primary DI / UDI-DI
08719425508795
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
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Indirect Bonding Tray Resins, Photo-Cured
8719425508795
GUDID
NPAGOICL01000

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

Other properties (21)

  • 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
  • Expiration Date: No
  • Manufacturing Date: No