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E - Guide Tint

by Vertex-Dental B.V.

Ref NPENSGOR01000Model Surgical Guide 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 Number871942550NDSGA16T6 Basic UDI-DI 08719425500041UDI-DIDate25 Jul 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08719425500041 UDI-DI Date22 Nov 2017ListedStatusListed 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  • Withdrawn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
E - Guide Tint EUDAMED
Vertex-Dental BV GUDID
Generic Name
Dental guided surgery reference plate
Model / Reference
Surgical Guide Resins, Photo-Cured, NPENSGOR01000
Primary DI / UDI-DI
08719425500041
Basic UDI-DI
871942550NDSGA16T6
FDA Product Code
NDP
EMDN Code
Q0102050199 Dentistry resins - other
GMDN Term
Dental guided surgery reference plate
Device Class
Class I
Regulation Number
872.3980
EU market of registration
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

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