510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K071490Substantially Equivalent

Leone Orthodontic Mini Implant

Leone S.p.A., Sesto, Fiorentino, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071490 is the FDA 510(k) clearance record for LEONE ORTHODONTIC MINI IMPLANT, a class II device, cleared for Leone S.P.A. on under FDA product code OAT (Implant, Endosseous, Orthodontic). FDA's definition for product code OAT reads: "It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed". FDA records list 2 510(k) clearances for Leone S.P.A., from to . As of , FDA records show no recalls naming K071490.

Clearance record

Decision date
Received
(268 days to decision)
Product code
OAT Implant, Endosseous, Orthodontic
Regulation
21 CFR 872.3640
Device class
Class II
Review panel
Dental
Applicant
Leone S.P.A. 50, Via P. A Quaracchi, Sesto, Fiorentino, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OAT

Trailing 12 months
1 clearance under product code OAT in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OAT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260