510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242944Substantially Equivalent

Leone Orthodontic Implant TAD (Temporary Anchorage Device)

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

K242944 is the FDA 510(k) clearance record for Leone Orthodontic Implant TAD (Temporary Anchorage Device), 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 one 510(k) clearance for Leone S.P.A. As of , FDA records show no recalls naming K242944.

Clearance record

Decision date
Received
(267 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. Via P.A Quaracchi, 50, 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