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Plastic Chain

by American Orthodontics 84 variants

Ref 854-284

Plastic Chain (854-284) 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 01907460000156E2) and listed in FDA GUDID since 22 Jul 2022 (UDI-DI 00190746058684), 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 Number01907460000156E2 Basic UDI-DI 00190746058684UDI-DIDate30 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00190746058684 UDI-DI Date22 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 01907460000156E2 registered 30 Jul 2025 Active
  • FDA GUDID UDI-DI 00190746058684 listed 22 Jul 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00190746058684
  2. Registered EUDAMED 01907460000156E2

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  • Withdrawn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
Plastic Chain EUDAMED
Colored Chain GUDID
Generic name
Orthodontic inter-arch elastic band
Model / Ref / Catalog
854-284
Description
CHAIN PLASTIC 15' CLOSED ORANGE
Primary DI / UDI-DI
00190746058684
Basic UDI-DI
01907460000156E2
FDA product code
ECI
EMDN code
Q010404 Orthodontic elastics, chains and springs
GMDN term
Orthodontic inter-arch elastic band
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

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

Related devices

Category: Orthodontic retainer

Similar devices in this category

Other devices filed under ORTHODONTIC ELASTICS, CHAINS AND SPRINGS.

Other devices from American Orthodontics

See all devices from American Orthodontics →

Properties

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