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Enigma

by Davis Schottlander & Davis Ltd 1,000+ variants

Ref ET:B1:D66KModel Enigma Denture Teeth - Pairs

Enigma (ET:B1:D66K) is a device classified as Class IIa in the EU and Class II in the US made by Davis Schottlander & Davis Ltd, registered in EUDAMED on 28 Apr 2026 (Basic UDI-DI B-05052674041150) and listed in FDA GUDID since 1 Jul 2024 (UDI-DI 05052674041150), active as of 23 Oct 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05052674041150 Basic UDI-DI 05052674041150UDI-DIDate28 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05052674041150 UDI-DI Date1 Jul 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05052674041150 registered 28 Apr 2026 Active
  • FDA GUDID UDI-DI 05052674041150 listed 1 Jul 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05052674041150
  2. Registered EUDAMED B-05052674041150

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Enigma EUDAMED
Enigma Denture Teeth - Pairs GUDID
Generic name
Resin artificial teeth
Device name
ET:B1:D66K
Model / reference
Enigma Denture Teeth - Pairs, ET:B1:D66K
Primary DI / UDI-DI
05052674041150
Basic UDI-DI
B-05052674041150
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
EU registration type
Legacy device (under a directive)
EU 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

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
GB-MF-000035008
Authorised representative
Schottlander (IRL) Ltd IE-AR-000029625

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from Davis Schottlander & Davis Ltd

See all devices from Davis Schottlander & Davis Ltd →

Properties

  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)