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) (6) Accessories, Implant, Dental, Endosseous (NDP) (4)

Premarket Exempt

No Yes

Clear

PRIMUS Implant System - 00810112921403 Catalog Number :

Device Description : Biotem AR CEMENTED ABUTMENT(NON-HEX) 6.5Ø X 5.5mm(Cuff:5)

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

PRIMUS Implant System - 00810112921410 Catalog Number :

Device Description : Biotem AR CEMENTED ABUTMENT(NON-HEX) 6.5Ø X 5.5mm(Cuff:6)

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

PRIMUS Implant System - 00810112921427 Catalog Number :

Device Description : BIOTEM AR CEMENTED ABUTMENT(NON-HEX) 6.5mm X 1mm(cuff) X 7mm(height)

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

PRIMUS Implant System - 00810112921434 Catalog Number :

Device Description : BIOTEM AR CEMENTED ABUTMENT(NON-HEX) 6.5mm X 2mm(cuff) X 7mm(height)

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

PRIMUS Implant System - 00810112921441 Catalog Number :

Device Description : BIOTEM AR CEMENTED ABUTMENT(NON-HEX) 6.5mm X 3mm(cuff) X 7mm(height)

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

PRIMUS Implant System - 00810112921458 Catalog Number :

Device Description : BIOTEM AR CEMENTED ABUTMENT(NON-HEX) 6.5mm X 4mm(cuff) X 7mm(height)

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

Transfer Impression Coping - 00810112921465 Catalog Number :

Device Description : Biotem AR TRANSFER IMPRESSION COPING(HEX) Ø4.0-11mm for mini

Device Class : 1

Duns Number: 101803383

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Transfer Impression Coping - 00810112921472 Catalog Number :

Device Description : Biotem AR TRANSFER IMPRESSION COPING(HEX) Ø4.0-14mm for mini

Device Class : 1

Duns Number: 101803383

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Transfer Impression Coping - 00810112921489 Catalog Number :

Device Description : Biotem AR TRANSFER IMPRESSION COPING(HEX) Ø4.0-11mm for standard

Device Class : 1

Duns Number: 101803383

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Transfer Impression Coping - 00810112921496 Catalog Number :

Device Description : Biotem AR TRANSFER IMPRESSION COPING(HEX) Ø4.0-14mm for standard

Device Class : 1

Duns Number: 101803383

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

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