AMERICAN DENTAL IMPLANT CORPORATION

Address:2415 WILMINGTON RD.,New Castle,PA,16105,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) (6) Accessories, Implant, Dental, Endosseous (NDP) (3) Abutment, Implant, Dental, Endosseous (NHA) (1)

Premarket Exempt

Yes No

Clear

American Dental Implant - D8963AS0 Catalog Number : 3AS

Device Description : 3.0mm Abutment Screw (1.25mm/.050"hex drive)

Device Class : 1

Duns Number: 835556429

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

American Dental Implant - D8963ASAB0 Catalog Number : 3AS-AB

Device Description : 3.0mm Angled Abutment Screw (1.25mm/.050"hex drive) - Anodized Blue

Device Class : 1

Duns Number: 835556429

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

American Dental Implant - D8963ASB0 Catalog Number : 3AS-B

Device Description : 3.0mm Abutment Screw - Anodized Blue (1.25mm/.050"hex drive)

Device Class : 1

Duns Number: 835556429

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

American Dental Implant - D8963CS0 Catalog Number : 3CS

Device Description : 3.0mm First Stage Surgical Cover Screw (.050 Hex Drive)

Device Class : 2

Duns Number: 835556429

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

American Dental Implant - D8964708HA0 Catalog Number : 4708HA

Device Description : 4.7mm x 08mm Wide Diameter Internal Hex Dental Implant HA Surface

Device Class : 2

Duns Number: 835556429

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

American Dental Implant - D8964708RBM0 Catalog Number : 4708RBM

Device Description : 4.7mm x 08mm Wide Diameter Internal Hex Dental Implant RBM Surface

Device Class : 2

Duns Number: 835556429

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

American Dental Implant - D8964710HA0 Catalog Number : 4710HA

Device Description : 4.7mm x 10mm Wide Diameter Internal Hex Dental Implant HA Surface

Device Class : 2

Duns Number: 835556429

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

American Dental Implant - D8964710RBM0 Catalog Number : 4710RBM

Device Description : 4.7mm x 10mm Wide Diameter Internal Hex Dental Implant RBM Surface

Device Class : 2

Duns Number: 835556429

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

American Dental Implant - D89647115HA0 Catalog Number : 47115HA

Device Description : 4.7mm x 11.5mm Wide Diameter Internal Hex Dental Implant HA Surface

Device Class : 2

Duns Number: 835556429

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

American Dental Implant - D89647115RBM0 Catalog Number : 47115RBM

Device Description : 4.7mm x 11.5mm Wide Diameter Internal Hex Dental Implant RBM Surface

Device Class : 2

Duns Number: 835556429

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

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