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

Implant, Endosseous, Root-Form (DZE) (10)

Premarket Exempt

No Yes

Clear

Bone Level Fixture - 00810112920000 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø3.7 X 7.5mm

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Bone Level Fixture - 00810112920017 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø3.7 X 8.5mm

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Bone Level Fixture - 00810112920024 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø3.7 X 10.0mm

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Bone Level Fixture - 00810112920031 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø3.7 X 11.5mm

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Bone Level Fixture - 00810112920048 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø3.7 X 13.0mm

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Bone Level Fixture - 00810112920055 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø3.7 X 15.0mm

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Bone Level Fixture - 00810112920062 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.2 X 7.5mm

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Bone Level Fixture - 00810112920079 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.2 X 8.5mm

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Bone Level Fixture - 00810112920086 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.2 X 10.0mm

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Bone Level Fixture - 00810112920093 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.2 X 11.5mm

Device Class : 2

Duns Number: 101803383

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

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