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Mesial Jet

by American Orthodontics

Ref 855-522

Mesial Jet (855-522) is a device classified as Class IIa in the EU and Class I in the US made by American Orthodontics, registered in EUDAMED on 30 Jul 2025 (Basic UDI-DI 01907460000171DW) and listed in FDA GUDID since 24 Jun 2019 (UDI-DI 00190746075575), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01907460000171DW Basic UDI-DI 00190746075575UDI-DIDate30 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00190746075575 UDI-DI Date24 Jun 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 01907460000171DW registered 30 Jul 2025 Active
  • FDA GUDID UDI-DI 00190746075575 listed 24 Jun 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00190746075575
  2. Registered EUDAMED 01907460000171DW

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  • Withdrawn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
Orthodontic palate expander/teeth aligner, bonded
Model / Ref / Catalog
855-522
Primary DI / UDI-DI
00190746075575
Basic UDI-DI
01907460000171DW
FDA product code
DYJ
EMDN code
Q010499 Orthodontic devices - other
GMDN term
Orthodontic palate expander/teeth aligner, bonded
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.5410
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Manufacturer details

EUDAMED SRN
US-MF-000007702
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Similar devices in this category

Other devices filed under ORTHODONTIC DEVICES - OTHER.

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Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)