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

Abutment, Implant, Dental, Endosseous (NHA) (4) Accessories, Implant, Dental, Endosseous (NDP) (3)

Premarket Exempt

No Yes

Clear

AIMGEN MAX - 08800024957630 Catalog Number : ATW-CN-PA

Device Description : AIMGEN MAX Torque Wrench Connector Square 4.0mm

Device Class : 1

Duns Number: 694197900

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

AIMGEN MAX - 08800024957647 Catalog Number : KIT-M-PA

Device Description : AIMGEN MAX Multi Transfer Impression Coping Multi / Ø4.8

Device Class : 2

Duns Number: 694197900

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

AIMGEN MAX - 08800024957654 Catalog Number : AMS-15-PA

Device Description : AIMGEN MAX Multi Straight Abutment Ø4.8 / GH=1.5mm

Device Class : 1

Duns Number: 694197900

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

AIMGEN MAX - 08800024957661 Catalog Number : AMS-25-PA

Device Description : AIMGEN MAX Multi Straight Abutment Ø4.8 / GH=2.5mm

Device Class : 2

Duns Number: 694197900

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

AIMGEN MAX - 08800024957678 Catalog Number : AMS-35-PA

Device Description : AIMGEN MAX Multi Straight Abutment Ø4.8 / GH=3.5mm

Device Class : 2

Duns Number: 694197900

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

AIMGEN MAX - 08800024957685 Catalog Number : MDA-351055H-PA

Device Description : AIMGEN MAX Duplex Abutment Ø3.5 / GH=1.0mm / PH=5.5mm / Hex

Device Class : 2

Duns Number: 694197900

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

AIMGEN MAX - 08800024957692 Catalog Number : MDA-351555H-PA

Device Description : AIMGEN MAX Duplex Abutment Ø3.5 / GH=1.5mm / PH=5.5mm / Hex

Device Class : 1

Duns Number: 694197900

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

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