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

Accessories, Implant, Dental, Endosseous (NDP) (10)

Premarket Exempt

No Yes

Clear

Transfer Impression Coping - 00810112921502 Catalog Number :

Device Description : Biotem AR TRANSFER IMPRESSION COPING(HEX) Ø5.0-11mm for standard

Device Class : 1

Duns Number: 101803383

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Transfer Impression Coping - 00810112921519 Catalog Number :

Device Description : Biotem AR TRANSFER IMPRESSION COPING(HEX) Ø5.0-14mm for standard

Device Class : 1

Duns Number: 101803383

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Pick-Up Impression Coping - 00810112921526 Catalog Number :

Device Description : Biotem AR PICK UP IMPRESSION COPING(HEX)3.4Ø X 10.0mm(Hex)

Device Class : 1

Duns Number: 101803383

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Pick-Up Impression Coping - 00810112921533 Catalog Number :

Device Description : Biotem AR PICK UP IMPRESSION COPING(HEX)3.4Ø X 13.0mm(Hex)

Device Class : 1

Duns Number: 101803383

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Pick-Up Impression Coping - 00810112921540 Catalog Number :

Device Description : Biotem AR PICK UP IMPRESSION COPING(HEX)4.5Ø X 10.0mm(Hex)

Device Class : 1

Duns Number: 101803383

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Pick-Up Impression Coping - 00810112921557 Catalog Number :

Device Description : Biotem AR PICK UP IMPRESSION COPING(HEX)4.5Ø X 13.0mm(Hex)

Device Class : 1

Duns Number: 101803383

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Pick-Up Impression Coping - 00810112921564 Catalog Number :

Device Description : Biotem AR PICK UP IMPRESSION COPING(HEX)5.5Ø X 10.0mm(Hex)

Device Class : 1

Duns Number: 101803383

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Fixture Lab Analog - 00810112921571 Catalog Number :

Device Description : Biotem AR FIXTURE LAB ANALOG 3.4Ø(aqua)

Device Class : 1

Duns Number: 101803383

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Fixture Lab Analog - 00810112921588 Catalog Number :

Device Description : Biotem AR FIXTURE LAB ANALOG 3.7Ø(Regular)

Device Class : 1

Duns Number: 101803383

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Fixture Lab Analog - 00810112921595 Catalog Number :

Device Description : Biotem AR FIXTURE LAB ANALOG 4.0Ø, 4.5Ø, 5.0Ø

Device Class : 1

Duns Number: 101803383

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

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