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Leone S.P.A.

Italy · Sesto Fiorentino

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Australia, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class II 5

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

11registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

9 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

26active ARTG entries

Class I 12IIa 10IIb 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 1 1Class 2a 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States0 registration records, 4 510(k), 0 PMA, 1 excluded

Brazil5 confirmed, 2 excluded

Saudi Arabia11 confirmed, 0 excluded

Manufacturer names merged into this page: LEONE S.P.A. · Leone s.p.a. · LEONE S.P.A

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242944	Leone Orthodontic Implant TAD (Temporary Anchorage Device)	2025-06-19
US	K071490	LEONE ORTHODONTIC MINI IMPLANT	2008-02-22
US	K070483	LEONE MONOIMPLANT FOR O-RING OVERDENTURE	2007-04-19
BR	10241259002	LEAF SELF CAD-CAM EXPANDER EXPANSOR ORTODONTICO LEONE	Class II
BR	10241259003	LEAF SELF EXPANDER EXPANSOR ORTODONTICO LEONE	Class II
BR	10241259004	LEAF CAD-CAM EXPANDER EXPANSOR ORTODÔNTICO LEONE	Class II
SA	ME0000009467SFDAA00013	NATURAL PROTECTIVE WAX	—
SA	ME0000009192SFDAA00009	Extraoral devices	—

Leone S.P.A.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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