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Leone Implant System

by Leone S.P.A.

510(k) K050586

Leone Implant System is a Class II device made by Leone S.P.A., cleared under FDA 510(k) K050586 on 27 Feb 2006, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK050586 Date27 Feb 2006ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

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