ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

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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

Wire, Orthodontic (DZC) (5) Spring, Orthodontic (ECO) (3) Band, Elastic, Orthodontic (ECI) (1) Positioner, Tooth, Preformed (KMY) (1)

Premarket Exempt

Yes

Clear

ORTHOMETRIC FLEXY NITI THERMO ACTIVE - 07898488900416 Catalog Number : 51.35.2519

Device Description : ARCHWIRE FLEXY NITI THERMAL 35° RECT. 0,019" X 0,025" UPPER

Device Class : 1

Duns Number: 898330003

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

ORTHOMETRIC FLEXY NITI THERMO ACTIVE - 07898488900423 Catalog Number : 52.35.2519

Device Description : ARCHWIRE FLEXY NITI THERMAL 35° RECT. 0,019" X 0,025" LOWER

Device Class : 1

Duns Number: 898330003

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

ORTHOMETRIC FLEXY NITI THERMO ACTIVE - 07898488900430 Catalog Number : 51.35.2521

Device Description : ARCHWIRE FLEXY NITI THERMAL 35° RECT. 0,021" X 0,025" UPPER

Device Class : 1

Duns Number: 898330003

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

ORTHOMETRIC FLEXY NITI THERMO ACTIVE - 07898488900447 Catalog Number : 52.35.2521

Device Description : ARCHWIRE FLEXY NITI THERMAL 35° RECT. 0,021" X 0,025" LOWER

Device Class : 1

Duns Number: 898330003

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

ORTHOMETRIC PRO ALIGNER X - 07898488900614 Catalog Number : 30.11.0053

Device Description : ALIGNER SHEETS- PRO ALIGNER X- Ø 125 X 0,76 MM- PCT 25 UN

Device Class : 1

Duns Number: 898330003

Premarket Exempt : Yes

Product Code : KMY

Prescription Use : Yes

Device Count : 1

ORTHOMETRIC FLEY NITI SPRINGS - 07898488900669 Catalog Number : 35.20.0007

Device Description : WIRE FLEXY NITI- CLOSE SPRING 7MM

Device Class : 1

Duns Number: 898330003

Premarket Exempt : Yes

Product Code : ECO

Prescription Use : Yes

Device Count : 1

ORTHOMETRIC FLEY NITI SPRINGS - 07898488900676 Catalog Number : 35.20.0009

Device Description : WIRE FLEXY NITI- CLOSE SPRING 9MM

Device Class : 1

Duns Number: 898330003

Premarket Exempt : Yes

Product Code : ECO

Prescription Use : Yes

Device Count : 1

ORTHOMETRIC FLEY NITI SPRINGS - 07898488900683 Catalog Number : 35.20.0010

Device Description : WIRE FLEXY NITI- OPEN SPRING

Device Class : 1

Duns Number: 898330003

Premarket Exempt : Yes

Product Code : ECO

Prescription Use : Yes

Device Count : 1

ORTHOMETRIC SS - 07898488900720 Catalog Number : 51.50.2800

Device Description : ARCHWIRE STAINLESS STEEL SS SEQUENCE- ROUND & RECT.

Device Class : 1

Duns Number: 898330003

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

ORTHOMETRIC ELASTOMERICS - STICK LIGATURE - 07898488900768 Catalog Number : 60.03.2904

Device Description : ORTHOMETRIC ELASTOMERICS-STICK LIGATURE-ASSORTMENT OF COLORS-50 UN

Device Class : 1

Duns Number: 898330003

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

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