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) (6) Plier, Orthodontic (JEX) (4)

Premarket Exempt

No Yes

Clear

LEONE SPA - 08033707101932 Catalog Number : R7101-02

Device Description : DISCS HARD/SOFT Ø 120mm THICK 2mm

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : DYJ

Prescription Use : Yes

Device Count : 1

LEONE SPA - 08033707101949 Catalog Number : R7101-03

Device Description : DISCS HARD/SOFT Ø 120mm THICK 3mm

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : DYJ

Prescription Use : Yes

Device Count : 1

LEONE SPA - 08033707101956 Catalog Number : R7102-02

Device Description : DISCS HARD/SOFT Ø 125mm THICK 2mm

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : DYJ

Prescription Use : Yes

Device Count : 1

LEONE SPA - 08033707101963 Catalog Number : R7102-03

Device Description : DISCS HARD/SOFT Ø 125mm THICK 3mm

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : DYJ

Prescription Use : Yes

Device Count : 1

LEONE SPA - 08033707101970 Catalog Number : R7113-02

Device Description : PLATES HARD/SOFT 125x125 THICK 2mm

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : DYJ

Prescription Use : Yes

Device Count : 1

LEONE SPA - 08033707101987 Catalog Number : R7113-03

Device Description : PLATES HARD/SOFT 125x125 THICK 3mm

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : DYJ

Prescription Use : Yes

Device Count : 1

LEONE SPA - 08033707102137 Catalog Number : P4075-00

Device Description : THREE JAW PLIERS

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : JEX

Prescription Use : Yes

Device Count : 1

LEONE SPA - 08033707102144 Catalog Number : P4089-00

Device Description : MOSQUITO FORCEPS 12 cm STRAIGHT

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : JEX

Prescription Use : Yes

Device Count : 1

LEONE SPA - 08033707102168 Catalog Number : P4154-00

Device Description : ARCHWIRE BENDING PLIERS DISTAL

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : JEX

Prescription Use : Yes

Device Count : 1

LEONE SPA - 08033707102175 Catalog Number : P4160-00

Device Description : PLIERS MATHIEU 14 CM

Device Class : 1

Duns Number: 432167294

Premarket Exempt : Yes

Product Code : JEX

Prescription Use : Yes

Device Count : 1

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