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) (3) Sealant, Pit And Fissure, And Conditioner (EBC) (3) Agent, Tooth Bonding, Resin (KLE) (2) Denture Preformed (Partially Prefabricated Denture) (EKO) (2)

Premarket Exempt

No Yes

Clear

AuraVeneer Cement - D820AVOPW0 Catalog Number : AVOPW

Device Description : Aura Veneer Cement - 1.2 mL Single Syringe Opaque White

Device Class : 2

Duns Number: 191036107

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

AuraVeneer Cement - D820AVOW Catalog Number : AVOW

Device Description : Cement, Dental.

Device Class : 2

Duns Number: 191036107

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

Bonita Pit and Fissure Sealant - D820BONNT0 Catalog Number : BONNT

Device Description : Pit and Fissure Sealant, Dental.

Device Class :

Duns Number: 191036107

Premarket Exempt : No

Product Code : EBC

Prescription Use : No

Device Count : 1

Bonita Pit and Fissure Sealant - D820BONOW0 Catalog Number : BONOW

Device Description : Pit and Fissure Sealant, Dental.

Device Class : 2

Duns Number: 191036107

Premarket Exempt : No

Product Code : EBC

Prescription Use : No

Device Count : 1

ClearVue Pit & Fissure Sealant and Sealer - D820CV0 Catalog Number : CV

Device Description : Pit & Fissure Sealant and Sealer, Dental.

Device Class :

Duns Number: 191036107

Premarket Exempt : No

Product Code : EBC

Prescription Use : No

Device Count : 1

Denali Etching Gel - D820DETCH120 Catalog Number : DETCH12

Device Description : Etching Gel, Dental.

Device Class : 2

Duns Number: 191036107

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

Denali Etching Gel - D820DETCH30 Catalog Number : DETCH3

Device Description : Etching Gel, Dental.

Device Class : 2

Duns Number: 191036107

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

Harmony Implant Cement - D820HAR0 Catalog Number : HAR

Device Description : Cement, Dental.

Device Class : 2

Duns Number: 191036107

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

HIRO Light Cure Pattern, Modeling and Indexing Resin - D820HIRO0 Catalog Number : HIRO

Device Description : Light Cure Pattern, Modeling and Indexing Resin.

Device Class :

Duns Number: 191036107

Premarket Exempt : Yes

Product Code : EKO

Prescription Use : Yes

Device Count : 1

Jazzy DC Acrylic Resin - D820JAZ0 Catalog Number : JAZ

Device Description : Dual Cure Pattern, Modeling, and Indexing Resin.

Device Class : 2

Duns Number: 191036107

Premarket Exempt : Yes

Product Code : EKO

Prescription Use : Yes

Device Count : 1

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