Dentsply Implants Manufacturing GmbH

Address:Rodenbacher Chaussee 4,Hanau Hesse,DE

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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

Accessories, implant, dental, endosseous (NDP) (8) IMPLANT, ENDOSSEOUS, ROOT-FORM (DZE) (2)

Premarket Exempt

No Yes

Clear

Astra Tech Implant System® - 07392532002823 Catalog Number : 22809

Device Description : Twist Drill Ø 3.7, 8-19 mm

Device Class : 1

Duns Number: 344038836

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Astra Tech Implant System® - 07392532002830 Catalog Number : 22810

Device Description : Twist Drill Ø 3.85 8-19 mm

Device Class : 1

Duns Number: 344038836

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Astra Tech Implant System® - 07392532002847 Catalog Number : 22811

Device Description : Twist Drill Ø 3.2, 8-13 mm

Device Class : 1

Duns Number: 344038836

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Astra Tech Implant System® - 07392532002854 Catalog Number : 22812

Device Description : Twist Drill Ø 3.35, 8-13 mm

Device Class : 1

Duns Number: 344038836

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Astra Tech Implant System® - 07392532002861 Catalog Number : 22813

Device Description : Twist Drill Ø 3.7, 8-13 mm

Device Class : 1

Duns Number: 344038836

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Astra Tech Implant System® - 07392532002878 Catalog Number : 22814

Device Description : Twist Drill Ø 3.85, 8-13 mm

Device Class : 1

Duns Number: 344038836

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Astra Tech Implant System® - 07392532002885 Catalog Number : 22815

Device Description : Cortical Drill Ø 3.2/3.5 S

Device Class : 1

Duns Number: 344038836

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Astra Tech Implant System® - 07392532002892 Catalog Number : 22816

Device Description : Cortical Drill Ø 3.7/4.0 S

Device Class : 1

Duns Number: 344038836

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

ASTRA TECH Implant System® - 07392532002977 Catalog Number : 22827

Device Description : Cast-to Abutment 3.5 NI

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

ASTRA TECH Implant System® - 07392532002984 Catalog Number : 22828

Device Description : Cast-to Abutment 4.0 NI

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

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