CAGENIX, INC.

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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) Denture, Plastic, Teeth (ELM) (1)

Premarket Exempt

No Yes

Clear

Cagenix AccuFrame - 90860002441903 Catalog Number :

Device Description : Titanium framework for supporting multi implant restorations

Device Class : 2

Duns Number: 030868250

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Cagenix AccuFrame IC - 90860002441910 Catalog Number :

Device Description : AccuFrame Titanium Framework to support a series of individual crowns

Device Class : 2

Duns Number: 030868250

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Cagenix AccuFrame 360 - 90860002441927 Catalog Number :

Device Description : AccuFrame Titanium Framework to support milled overlay

Device Class : 2

Duns Number: 030868250

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Cagenix AccuFrame Overdenture - 90860002441934 Catalog Number :

Device Description : AccuFrame Titanium Framework to support milled overdenture

Device Class : 2

Duns Number: 030868250

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Cagenix BarZero - 90860002441941 Catalog Number :

Device Description : Milled denture teeth for dental restoration

Device Class : 2

Duns Number: 030868250

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : Yes

Device Count : 1

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