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Enigma Denture Teeth - Pairs ET:C4:D36L

by Davis Schottlander & Davis Limited EUDAMEDGUDID

Active European Union

Ref ET:C4:D36LModel Enigma Denture Teeth - Pairs

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05052674040467 Basic UDI-DIDate28 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05052674040467 UDI-DIDate1 Jul 2024ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Enigma EUDAMED
Enigma Denture Teeth - Pairs GUDID
Generic Name
Resin artificial teeth
Device Name
ET:C4:D36L
Model / Reference
ET:C4:D36L, Enigma Denture Teeth - Pairs
Primary DI / UDI-DI
05052674040467
Basic UDI-DI
B-05052674040467
FDA Product Code
ELM
EMDN Code
P01020180 Dental implants - accessories
GMDN Term
Resin artificial teeth
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3590
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Weight — 0.003 Kilogram

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No