DHARMA RESEARCH, 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

Agent, Tooth Bonding, Resin (KLE) (10)

Premarket Exempt

Clear

Jade - 00353045000628 Catalog Number : 20-00005

Device Description : Jade Blue 37% Phosphoric Acid Etchant Gel - 1 x 50ml Syringe, 50 Pre-bent 23ga T Jade Blue 37% Phosphoric Acid Etchant Gel - 1 x 50ml Syringe, 50 Pre-bent 23ga Tips, 4 x 1.2ml Empty Syringes & Instruction InsertInstruction Insert

Device Class : 2

Duns Number: 078444642

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

Jade - 00353045000635 Catalog Number : 20-00002

Device Description : Jade Blue 37% Phosphoric Acid Etchant Gel - 1 x 10ml Syringe, 20 Pre-bent 23ga T Jade Blue 37% Phosphoric Acid Etchant Gel - 1 x 10ml Syringe, 20 Pre-bent 23ga Tips & Instruction Insert

Device Class : 2

Duns Number: 078444642

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

Jade - 00353045000642 Catalog Number : 20-00003

Device Description : Jade Blue 37% Phosphoric Acid Etchant Gel Kit - 4 x 1.2ml Syringes, 20 Pre-bent Jade Blue 37% Phosphoric Acid Etchant Gel Kit - 4 x 1.2ml Syringes, 20 Pre-bent 23ga Tips & Instruction Insert

Device Class :

Duns Number: 078444642

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 4

Jade - 00353045000659 Catalog Number : 20-00004

Device Description : Jade Blue 37% Phosphoric Acid Etchant Gel Kit - 25 x 1.2ml Syringes, 50 Pre-bent Jade Blue 37% Phosphoric Acid Etchant Gel Kit - 25 x 1.2ml Syringes, 50 Pre-bent 23ga Tips & Instruction Insert

Device Class :

Duns Number: 078444642

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 25

Jade - 00353045000666 Catalog Number : 20-00001

Device Description : Jade Blue 37% Phosphoric Acid Etchant Gel - 1 x 10ml Syringe, 5 Pre-bent 23ga Ti Jade Blue 37% Phosphoric Acid Etchant Gel - 1 x 10ml Syringe, 5 Pre-bent 23ga Tips & 1 Instruction Insert

Device Class : 2

Duns Number: 078444642

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

Jade - 00353045000673 Catalog Number : 20-00006

Device Description : Jade Green 37% Phosphoric Acid Etchant Gel - 1 x 10ml Syringe, 5 Pre-bent 23ga T Jade Green 37% Phosphoric Acid Etchant Gel - 1 x 10ml Syringe, 5 Pre-bent 23ga Tips & Instruction Insert

Device Class : 2

Duns Number: 078444642

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

Jade - 00353045000680 Catalog Number : 20-00007

Device Description : Jade Green 37% Phosphoric Acid Etchant Gel - 1 x 10ml Syringe, 20 Pre-bent 23ga Jade Green 37% Phosphoric Acid Etchant Gel - 1 x 10ml Syringe, 20 Pre-bent 23ga Tips & Instruction Insert

Device Class : 2

Duns Number: 078444642

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

Jade - 00353045000697 Catalog Number : 20-00008

Device Description : Jade Green 37% Phosphoric Acid Etchant Gel - 4 x 1.2ml Syringes, 20 Pre-bent 23g Jade Green 37% Phosphoric Acid Etchant Gel - 4 x 1.2ml Syringes, 20 Pre-bent 23ga Tips & Instruction Insert

Device Class :

Duns Number: 078444642

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 4

Jade - 00353045000703 Catalog Number : 20-00009

Device Description : Jade Green 37% Phosphoric Acid Etchant Gel - 25 x 1.2ml Syringes, 50 Pre-bent 23 Jade Green 37% Phosphoric Acid Etchant Gel - 25 x 1.2ml Syringes, 50 Pre-bent 23ga Tips & Instruction Insert

Device Class :

Duns Number: 078444642

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 25

Jade - 00353045000710 Catalog Number : 20-00010

Device Description : Jade Green 37% Phosphoric Acid Etchant Gel - 1 x 50ml Syringe, 50 Pre-bent 23ga Jade Green 37% Phosphoric Acid Etchant Gel - 1 x 50ml Syringe, 50 Pre-bent 23ga Tips, 4 x 1.2ml Empty Syringes & Instruction Insert

Device Class :

Duns Number: 078444642

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

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