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Orthodontic Bands

by Leone S.P.A. 1,000+ variants

Ref E8200-17

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

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Overview

Orthodontic bands are a popular and effective solution for orthodontic treatment. These custom-made bands use a combination of elastic materials to apply gentle pressure to the teeth, helping to move them into their desired positions. By applying consistent pressure over time, orthodontic bands can significantly improve the alignment of teeth, reducing the risk of orthodontic problems such as gaps and crookedness. Made from high-quality materials, orthodontic bands are easy to clean and maintain, making them a reliable choice for individuals seeking to improve their smile.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08033707027331 Basic UDI-DI 08033707027331UDI-DIDate15 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033707027331 UDI-DI Date24 Jul 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Leone SpA
Generic Name
Orthodontic metal band
Model / Ref / Catalog
E8200-17
Primary DI / UDI-DI
08033707027331
Basic UDI-DI
B-08033707027331
FDA Product Code
ECM
EMDN Code
Q010402 Orthodontic bands
GMDN Term
Orthodontic metal band
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.5410
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
IT-MF-000005986

Other devices from Leone S.P.A.

See all devices from Leone S.P.A. →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No