ODONTIT S.A.

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

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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

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

Premarket Exempt

Clear

Odontit - D914SG50080 Catalog Number : SG5008

Device Description : External Hex, cilindirical Rough Surface Acid Eatched Smart Grip 5.0 X 8mm

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SG50100 Catalog Number : SG5010

Device Description : External Hex, cilindirical Rough Surface Acid Eatched Smart Grip 5.0 X 10mm

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SGCL0 Catalog Number : SGCL

Device Description : SmartGrip driver handpiece

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SGDL0 Catalog Number : SGDL

Device Description : SmartGrip driver long

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SGDS0 Catalog Number : SGDS

Device Description : SmartGrip driver short

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SGH30100 Catalog Number : SGH3010

Device Description : External Hex, autoadvancing tapered Rough Surface Acid Eatched Smart Grip 3,75 X 10mm

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SGH30110 Catalog Number : SGH3011

Device Description : External Hex, autoadvancing tapered Rough Surface Acid Eatched Smart Grip 3,75 X 11.5mm

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SGH30130 Catalog Number : SGH3013

Device Description : External Hex, autoadvancing tapered Rough Surface Acid Eatched Smart Grip 3,75 X 13mm

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SGH40080 Catalog Number : SGH4008

Device Description : External Hex, autoadvancing tapered Rough Surface Acid Eatched Smart Grip 4.0 X 8mm

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SGH40100 Catalog Number : SGH4010

Device Description : External Hex, autoadvancing tapered 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

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