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Thunk3D Dentean

by Shenzhen Xunheng 3D Technology Co.Ltd China EUDAMED

Ref 6.80mm*7.80mm*4.70mm EMDN L15901199

Overview

Improve patient outcomes with the Thunk3D Dentean, a revolutionary implant orientation scan marker. With its advanced 3D technology and precise measurements, this device ensures accurate placement of dental implants, reducing complications and improving overall success rates.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697709224IOSM01SN Basic UDI-DIDate12 Jan 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
6.80mm*7.80mm*4.70mm
Primary DI / UDI-DI
06977092240017
Basic UDI-DI
697709224IOSM01SN
EMDN Code
L15901199 Positioning instruments for dental devices, reusable - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000039350
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • 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

Sources (1)

  • EUDAMED 2070ab52-819c-4cdd-b979-b57ae6505ef2 61 fields · synced 22 Oct 2026