Achimhai Medical Corporation

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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

Drill, Dental, Intraoral (DZA) (6) Abutment, Implant, Dental, Endosseous (NHA) (3) Implant, Endosseous, Root-Form (DZE) (1)

Premarket Exempt

No Yes

Clear

Nexplant - 08800024954561 Catalog Number : SD-4510

Device Description : Ø4.5 / L=9.5mm

Device Class : 1

Duns Number: 694197900

Premarket Exempt : No

Product Code : DZA

Prescription Use : Yes

Device Count : 1

Nexplant - 08800024954578 Catalog Number : SD-4511

Device Description : Ø4.5 / L=11.0mm

Device Class : 1

Duns Number: 694197900

Premarket Exempt : No

Product Code : DZA

Prescription Use : Yes

Device Count : 1

Nexplant - 08800024954585 Catalog Number : SD-5008

Device Description : Ø5.0 / L=8.0mm

Device Class : 1

Duns Number: 694197900

Premarket Exempt : No

Product Code : DZA

Prescription Use : Yes

Device Count : 1

Nexplant - 08800024954592 Catalog Number : SD-5010

Device Description : Ø5.0 / L=9.5mm

Device Class : 1

Duns Number: 694197900

Premarket Exempt : No

Product Code : DZA

Prescription Use : Yes

Device Count : 1

Nexplant - 08800024954608 Catalog Number : SD-5011

Device Description : Ø5.0 / L=11.0mm

Device Class : 1

Duns Number: 694197900

Premarket Exempt : No

Product Code : DZA

Prescription Use : Yes

Device Count : 1

Nexplant - 08800024954615 Catalog Number : PLT-DRL

Device Description : Ø2.0 / Ø2.7

Device Class : 1

Duns Number: 694197900

Premarket Exempt : No

Product Code : DZA

Prescription Use : Yes

Device Count : 1

AIMGEN MAX - 08800024954639 Catalog Number : PFX-3908SS-C

Device Description : AIMGEN MAX Implant System Φ3.5/L8.0

Device Class : 2

Duns Number: 694197900

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

NEXPLANT - 08800024955476 Catalog Number :

Device Description : Wide Healing Abutment Ø4.0 / H=3.5mm

Device Class : 2

Duns Number: 694197900

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

NEXPLANT - 08800024955483 Catalog Number :

Device Description : Wide Healing Abutment Ø4.0 / H=5.0mm

Device Class : 2

Duns Number: 694197900

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

NEXPLANT - 08800024955490 Catalog Number :

Device Description : Wide Healing Abutment Ø4.0 / H=7.0mm

Device Class : 2

Duns Number: 694197900

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

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