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

Cement, Dental (EMA) (7) Sealant, Pit And Fissure, And Conditioner (EBC) (3)

Premarket Exempt

No Yes

Clear

AuraLay XF Pit and Fissure Sealant - D820ALAYXFOW0 Catalog Number : ALAYXFOW

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 - D820ALAYXFOW3ML0 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

AuraOpaquer - D820AOP0 Catalog Number : AOP

Device Description : Opaquer, Dental.

Device Class :

Duns Number: 191036107

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

AuraOpaquer - D820AOW0 Catalog Number : AOW

Device Description : Opaquer, Dental.

Device Class : 2

Duns Number: 191036107

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

Aura Protective Sealer - D820APS0 Catalog Number : APS

Device Description : Protective Sealer, Dental.

Device Class :

Duns Number: 191036107

Premarket Exempt : No

Product Code : EBC

Prescription Use : No

Device Count : 1

AuraVeneer Cement - D820AV1C3OW0 Catalog Number : AV1C3OW

Device Description : Cement, Dental.

Device Class : 2

Duns Number: 191036107

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

AuraVeneer Cement - D820AV1OW3OPW0 Catalog Number : AV1OW3OPW

Device Description : AuraVeneer Cement. Kit of 4 x 1.2 ml Syringes. Shades: 1 Off White - 3 Opaque White

Device Class : 2

Duns Number: 191036107

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

AuraVeneer Cement - D820AV2C2OW0 Catalog Number : AV2C2OW

Device Description : Dental, Cement.

Device Class : 2

Duns Number: 191036107

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

AuraVeneer Cement - D820AV3C1OW0 Catalog Number : AV3C1OW

Device Description : Cement, Dental.

Device Class : 2

Duns Number: 191036107

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

AuraVeneer Cement - D820AVC0 Catalog Number : AVC

Device Description : Cement, Dental.

Device Class :

Duns Number: 191036107

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

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