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A0721-10

by Leone S.P.A.

Ref A0721-10Model BITE

A0721-10 is a device classified as Class IIa in the EU and Class I in the US made by Leone S.P.A., registered in EUDAMED on 10 Apr 2026 (Basic UDI-DI 080337070TDIIA001M02-8F) and listed in FDA GUDID since 10 Apr 2020 (UDI-DI 08033707000815), 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 Number080337070TDIIA001M02-8F Basic UDI-DI 08033707000815UDI-DIDate10 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033707000815 UDI-DI Date10 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 080337070TDIIA001M02-8F registered 10 Apr 2026 Active
  • FDA GUDID UDI-DI 08033707000815 listed 10 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08033707000815
  2. Registered EUDAMED 080337070TDIIA001M02-8F

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  • Withdrawn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
Leone SpA
Generic name
Orthodontic retainer
Model / Ref / Catalog
BITE, A0721-10
Primary DI / UDI-DI
08033707000815
Basic UDI-DI
080337070TDIIA001M02-8F
FDA product code
DYJ
EMDN code
Q010499 Orthodontic devices - other
GMDN term
Orthodontic retainer
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.5410
EU registration type
Standard device
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

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
IT-MF-000005986

Similar devices in this category

Other devices filed under ORTHODONTIC DEVICES - OTHER.

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 (21, all answered No)