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 - D914RATT20 Catalog Number : RATT2

Device Description : streight abutment 9 mm w/screw

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914RAUCLA0 Catalog Number : RA-UCLA

Device Description : castable abutment w/screw

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914RAUCLACR0 Catalog Number : RA-UCLA-CR

Device Description : castable CrCob metal base abutment w/screw

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914RE0 Catalog Number : RE

Device Description : Ratchet Wrench Extension - 16 mm

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914ROA0 Catalog Number : ROA

Device Description : O ring replace Pkg 5

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914ROA40 Catalog Number : ROA-4

Device Description : Oring replace Pkg 5

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914RW0 Catalog Number : RW

Device Description : Ratchet Wrench

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SBM0 Catalog Number : SBM

Device Description : Monoblock 3,75 driver

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SBN0 Catalog Number : SBN

Device Description : Monoblock 3,00 driver

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Odontit - D914SBO0 Catalog Number : SBO

Device Description : mini implant EQ -EB -EO SERIES driver

Device Class : 2

Duns Number: 972044937

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

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