DENALI CORPORATION

Address:134 Old Washington Street,Hanover,MA,02339,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

Sealant, Pit And Fissure, And Conditioner (EBC) (6) Cement, Dental (EMA) (2) Material, Tooth Shade, Resin (EBF) (2)

Premarket Exempt

No Yes

Clear

AuraCem DC 90 - D820ACEMC0 Catalog Number : ACEMC

Device Description : Cement, Dental.

Device Class : 2

Duns Number: 191036107

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

AuraCem DC90 Resin Cement - D820ACEMOW0 Catalog Number : ACEMOW

Device Description : Cement, Dental.

Device Class : 2

Duns Number: 191036107

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

AuraCore Buildup Material - D820ACOREEOW0 Catalog Number : COREEOW

Device Description : Core Buildup Material, Dental.

Device Class :

Duns Number: 191036107

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

AuraCore Buildup Material - D820ACORENOW0 Catalog Number : ACORENOW

Device Description : Core Buildup Material, Dental.

Device Class : 2

Duns Number: 191036107

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

AuraLay Pit & Fissure Sealant - D820ALAYNT0 Catalog Number : ALAYNT

Device Description : Pit and Fissure Sealant, Dental.

Device Class :

Duns Number: 191036107

Premarket Exempt : No

Product Code : EBC

Prescription Use : No

Device Count : 1

AuraLay Pit and Fissure Sealant - D820ALAYNT3ML0 Catalog Number : ALAYNT3ML

Device Description : Pit and Fissure Sealant, Dental.

Device Class :

Duns Number: 191036107

Premarket Exempt : No

Product Code : EBC

Prescription Use : No

Device Count : 1

AuraLay Pit and Fissure Sealant - D820ALAYOW0 Catalog Number :

Device Description : Pit and Fissure Sealant, Dental.

Device Class :

Duns Number: 191036107

Premarket Exempt : No

Product Code : EBC

Prescription Use : No

Device Count : 1

AuraLay Pit and Fissure Sealant - D820ALAYOW3ML0 Catalog Number : ALAYOW3ML

Device Description : Pit and Fissure Sealant, Dental.

Device Class :

Duns Number: 191036107

Premarket Exempt : No

Product Code : EBC

Prescription Use : No

Device Count : 1

AuraLay XF Pit and Fissure Sealant - D820ALAYXFNT0 Catalog Number : ALAYXFNT

Device Description : Pit and Fissure Sealant, Dental.

Device Class :

Duns Number: 191036107

Premarket Exempt : No

Product Code : EBC

Prescription Use : No

Device Count : 1

AuraLay XF Pit and Fissure Sealant - D820ALAYXFNT3ML0 Catalog Number : ALAYXFNT3

Device Description : Pit and Fissure Sealant

Device Class :

Duns Number: 191036107

Premarket Exempt : No

Product Code : EBC

Prescription Use : No

Device Count : 1

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