ODONTIT S.A.

Address:Necochea 854,BUENOS AIRES Buenos Aires, Ciudad Autonoma de,AR

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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

Implant, Endosseous, Root-Form (DZE) (10)

Premarket Exempt

Clear

Odontit - D914SG34080 Catalog Number : SG3408

Device Description : External Hex, cilindirical Rough Surface Acid Eatched Smart Grip 3,40 X 8mm

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SG34100 Catalog Number : SG3410

Device Description : External Hex, cilindirical Rough Surface Acid Eatched Smart Grip 3.40 X 10mm

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SG34110 Catalog Number : SG3411

Device Description : External Hex, cilindirical Rough Surface Acid Eatched Smart Grip 3,40 X 11.5mm

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SG34130 Catalog Number : SG3413

Device Description : External Hex, cilindirical Rough Surface Acid Eatched Smart Grip 3,40 X 13mm

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SG40100 Catalog Number : SG4010

Device Description : External Hex, cilindirical Rough Surface Acid Eatched Smart Grip 4.0 X 10mm

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SG40110 Catalog Number : SG4011

Device Description : External Hex, cilindirical Rough Surface Acid Eatched Smart Grip 4.0 X 11.5mm

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SG40130 Catalog Number : SG4013

Device Description : External Hex, cilindirical Rough Surface Acid Eatched Smart Grip 4.0 X 13mm

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SG40150 Catalog Number : SG4015

Device Description : External Hex, cilindirical Rough Surface Acid Eatched Smart Grip 4.0 X 15mm

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SG50050 Catalog Number : SG5005

Device Description : External Hex, cilindirical Rough Surface Acid Eatched Smart Grip 5.0 X 5mm

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SG50060 Catalog Number : SG5006

Device Description : External Hex, cilindirical Rough Surface Acid Eatched Smart Grip 5.0 X 6mm

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

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