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Crown Ns/Efucera Ns 4 Plate Sample

by Yamahachi Dental Mfg., Co. 75 variants

Ref 28*1SETS,S43SN4130,UL,A3.5

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

CE MDR

Valid until

12 Jun 2031

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier SGS Belgium NV

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
United StatesGUDID listing GUDID NumberD0804SCENZ100ULA350 UDI-DI Date19 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED NumberJP26/00000198 Date31 Jul 2026IssuedStatusActive expires 12 Jun 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • JP26/00000198 Active Amended

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    31 Jul 2026
    Expires
    12 Jun 2031
    Reason
    Other

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  • Withdrawn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

Generic Name
Resin artificial teeth
Device Name
Acrylic resin teeth (NS)
Model / Reference
28*1SETS, S43SN4130, UL, A3.5
Primary DI / UDI-DI
D0804SCENZ100ULA350
Basic UDI-DI
++D08038643NS9PF
FDA Product Code
ELM
EMDN Code
Q01020601 Mobile dental prostheses
GMDN Term
Resin artificial teeth
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3590
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
JP-MF-000024849
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Yamahachi Dental Mfg., Co.

See all devices from Yamahachi Dental Mfg., Co. →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

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