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Metal Brackets

by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda 288 variants

Part of a family of 297 devices: see the family page

Ref 20.12.0146

Metal Brackets (20.12.0146) is a device classified as Class IIa in the EU and Class I in the US made by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda, registered in EUDAMED on 11 Sep 2025 (Basic UDI-DI 789848890METALLIC2L) and listed in FDA GUDID since 27 Sep 2022 (UDI-DI 07898488909648), 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 Number789848890METALLIC2L Basic UDI-DI 07898488909648UDI-DIDate11 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07898488909648 UDI-DI Date27 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 789848890METALLIC2L registered 11 Sep 2025 Active
  • FDA GUDID UDI-DI 07898488909648 listed 27 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07898488909648
  2. Registered EUDAMED 789848890METALLIC2L

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  • Withdrawn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
Orthometric Tubes Premium Series
Generic name
Orthodontic tube
Device name
Metal Brackets
Model / Ref / Catalog
20.12.0146
Primary DI / UDI-DI
07898488909648
Basic UDI-DI
789848890METALLIC2L
FDA product code
DZD
EMDN code
Q010403 Orthodontic brackets and buttons
GMDN term
Orthodontic tube
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.5410
EU registration type
Standard device
EU market of registration
Portugal
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
BR-MF-000026426
Authorised representative
Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813

Related devices

Category: Orthodontic tube

Similar devices in this category

Other devices filed under ORTHODONTIC BRACKETS AND BUTTONS.

Other devices from Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda

See all devices from Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda →

Properties

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