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Dental 3D Print Resin

by Tianjin Dent Technology Co., Ltd.

Ref 001AModel 015A 015B 015C 015D 015E 015F 015G 015H 015I 015J 015K 015L 015M 015N 015O 015P 015Q 015R 015S 015T 015U 015V 015W 015X 015Y 015Z 016A 016B 016C 016D 016E 016F,etc

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697864977Dent0012P Basic UDI-DI 06978649770018UDI-DIDate8 May 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Dental 3D Print Resin
Model / Reference
015A 015B 015C 015D 015E 015F 015G 015H 015I 015J 015K 015L 015M 015N 015O 015P 015Q 015R 015S 015T 015U 015V 015W 015X 015Y 015Z 016A 016B 016C 016D 016E 016F,etc, 001A
Primary DI / UDI-DI
06978649770018
Basic UDI-DI
697864977Dent0012P
EMDN Code
Q0102050101 Temporary teeth resins
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047577
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties

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