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Porcelain Etch 407

by Ultradent Products, Inc.

Ref 407

Porcelain Etch 407 is a device classified as Class IIa in the EU and Class II in the US made by Ultradent Products, Inc., registered in EUDAMED on 29 May 2026 (Basic UDI-DI 0883205-TF052AW) and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00883205103635), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0883205-TF052AW Basic UDI-DI 00883205103635UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205103635 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0883205-TF052AW registered 29 May 2026 Active
  • FDA GUDID UDI-DI 00883205103635 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00883205103635
  2. Registered EUDAMED 0883205-TF052AW

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  • Withdrawn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
Porcelain Etch
Generic name
Dental tooth-etching solution
Model / Ref / Catalog
407
Primary DI / UDI-DI
00883205103635
Basic UDI-DI
0883205-TF052AW
FDA product code
EIH
EMDN code
Q01010402 Enamel-dentinal etching materials
GMDN term
Dental tooth-etching solution
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.6660
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
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.

Similar devices in this category

Other devices filed under ENAMEL-DENTINAL ETCHING MATERIALS.

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)