LEONE SPA

Address:50, VIA P. A QUARACCHI,Sesto Fiorentino Firenze,IT

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Retainer, Screw Expansion, Orthodontic (DYJ) (10) Plier, Orthodontic (JEX) (9)

Premarket Exempt

No Yes

Clear

LEONE SPA - 08033707000655 Catalog Number : A0665-06

Device Description : ONE-TOOTH SCREWS ROUNDED S/STEEL 6mm

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : DYJ, JEX

Prescription Use : Yes

Device Count : 1

LEONE SPA - 08033707000662 Catalog Number : A0665-09

Device Description : ONE-TOOTH SCREWS ROUNDED S/STEEL 9mm

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : DYJ, JEX

Prescription Use : Yes

Device Count : 1

LEONE SPA - 08033707000679 Catalog Number : A0665-95

Device Description : ONE-TOOTH SCREWS ROUNDED S/STEEL 6mm

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : DYJ, JEX

Prescription Use : Yes

Device Count : 1

LEONE SPA - 08033707000686 Catalog Number : A0665-96

Device Description : ONE-TOOTH SCREWS ROUNDED S/STEEL 9mm

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : DYJ, JEX

Prescription Use : Yes

Device Count : 1

LEONE SPA - 08033707000709 Catalog Number : A0668-95

Device Description : MICRO SPRING SCREW KIT

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : DYJ

Prescription Use : Yes

Device Count : 1

LEONE SPA - 08033707000723 Catalog Number : A0670-11

Device Description : MICRO SCREWS W/FRICTION S/STEEL 11mm

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : DYJ, JEX

Prescription Use : Yes

Device Count : 1

LEONE SPA - 08033707000747 Catalog Number : A0671-15

Device Description : STAND SCREWS W/FRICTION S/STEEL 15mm LW

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : DYJ, JEX

Prescription Use : Yes

Device Count : 1

LEONE SPA - 08033707000754 Catalog Number : A0671-95

Device Description : STAND SCREWS W/FRICTION S/STEEL 15mm LW

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : DYJ, JEX

Prescription Use : Yes

Device Count : 1

LEONE SPA - 08033707000761 Catalog Number : A0672-15

Device Description : STD SCREWS W/FRICT S/STEEL 15mm UPPER

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : DYJ, JEX

Prescription Use : Yes

Device Count : 1

LEONE SPA - 08033707000778 Catalog Number : A0672-95

Device Description : STAND SCREWS W/FRICTION S/STEEL 15mm UP

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : DYJ, JEX

Prescription Use : Yes

Device Count : 1

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