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FotoDent® tray2 D353003

by Dreve Dentamid GmbH

Ref D353003

FotoDent tray2 D353003 is a dental impression tray material (EU MDR Class I; FDA Class I; FDA product code EBH, Material, Impression Tray, Resin) made by Dreve Dentamid GmbH, registered in EUDAMED on 18 May 2026 (Basic UDI-DI ++E2390034Y7) and listed in FDA GUDID since 18 Apr 2023 (UDI-DI +E239D3530031), active as of 25 Oct 2026.

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

CE MDR

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E2390034Y7 Basic UDI-DI +E239D3530031UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+E239D3530031 UDI-DI Date18 Apr 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++E2390034Y7 registered 18 May 2026 Active
  • FDA GUDID UDI-DI +E239D3530031 listed 18 Apr 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID +E239D3530031
  2. Registered EUDAMED ++E2390034Y7

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  • Withdrawn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

Trade name
FotoDent® tray2
Generic name
Dental impression tray material
Device name
Lichthärtendes Material zur Herstellung von dentalen Abformlöffeln
Model / Ref / Catalog
D353003
Primary DI / UDI-DI
+E239D3530031 EUDAMED
E239D3530031 GUDID
Basic UDI-DI
++E2390034Y7
FDA product code
EBH
EMDN code
Q010503 Impression material trays, single-use
GMDN term
Dental impression tray material
Device class
Class I
Regulation number
872.3670
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+E239D3530031
GUDID
E239D3530031

The registries describe this device under different primary UDI-DIs (EUDAMED lists +E239D3530031; FDA GUDID lists E239D3530031), so their flags are not compared.

Related devices

Category: Dental impression tray material

Similar devices in this category

Other devices filed under IMPRESSION MATERIAL TRAYS, SINGLE-USE.

Other devices from Dreve Dentamid GmbH

See all devices from Dreve Dentamid GmbH →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)