Inosys, Inc.

Address:545 W 45th St Fl 11,New York,NY,10036,US

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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

Abutment, Implant, Dental, Endosseous (NHA) (10)

Premarket Exempt

No Yes

Clear

PRIMUS Implant System - 00810112920406 Catalog Number :

Device Description : Biotem AR HEALING ABUTMENTØ4.65 X 4.5 (C:3 , H:1.5)

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

PRIMUS Implant System - 00810112920413 Catalog Number :

Device Description : Biotem AR HEALING ABUTMENTØ4.65 ×6.5(C:4 , H:2.5)

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

PRIMUS Implant System - 00810112920420 Catalog Number :

Device Description : Biotem AR HEALING ABUTMENTØ5.65 X 2 (C:1 , H:1)

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

PRIMUS Implant System - 00810112920437 Catalog Number :

Device Description : Biotem AR HEALING ABUTMENTØ5.65 X 3(C:2 , H:1)

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

PRIMUS Implant System - 00810112920444 Catalog Number :

Device Description : Biotem AR HEALING ABUTMENTØ5.65 X 4.5 (C:3 , H:1.5)

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

PRIMUS Implant System - 00810112920451 Catalog Number :

Device Description : Biotem AR HEALING ABUTMENTØ5.65 ×6.5(C:4 , H:2.5)

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

PRIMUS Implant System - 00810112920468 Catalog Number :

Device Description : Biotem AR HEALING ABUTMENTØ6.65 X 2 (C:1 , H:1)

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

PRIMUS Implant System - 00810112920475 Catalog Number :

Device Description : Biotem AR HEALING ABUTMENTØ6.65 X 3(C:2 , H:1)

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

PRIMUS Implant System - 00810112920482 Catalog Number :

Device Description : Biotem AR HEALING ABUTMENTØ6.65 X 4.5 (C:3 , H:1.5)

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

PRIMUS Implant System - 00810112920499 Catalog Number :

Device Description : Biotem AR HEALING ABUTMENTØ6.65 ×6.5(C:4 , H:2.5)

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

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