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Leone Orthodontic Mini Implant

by Leone S.P.A.

510(k) K071490

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K071490↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK071490 Date22 Feb 2008ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K071490 decided 22 Feb 2008 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
OAT
Device class
Class II
Regulation
21 CFR Part 872.3640
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Leone Orthodontic Mini Implant is an endosseous orthodontic implant designed for temporary anchorage in dental applications. It provides a stable reference point for orthodontic treatment, facilitating tooth movement and alignment without relying on patient cooperation or traditional braces.

These implants are intended for single-use in orthodontic settings and require professional placement by licensed dental practitioners. Supplied sterile, they are classified as Class II devices under FDA regulations and comply with MDR authorisation. Multiple sizes and reference codes (e.g., 3009732568, 3011302692) are available for customised orthodontic procedures, with no MRI safety restrictions stated.

From the manufacturer

Leone orthodontic products: expansion screws, brackets, wires, bands and devices.

Source: leone.it

Leone S.p.A. - Products for Orthodontics and Implantology, courses and training.

Source: leone.it

Instructions General indications Leone products are intended exclusively for orthodontic, implantology and dental use and should only be used by skilled and licensed professionals, who will be held the sole responsible for the construction and the application of prostheses, partially of fully manufactured with the above mentioned products.

Source: service.leone.it

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