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

Varnish, Cavity (LBH) (3) Agent, Tooth Bonding, Resin (KLE) (2) Material, Impression (ELW) (2)

Premarket Exempt

Clear

Enthus - 00353045001878 Catalog Number : 38-00011

Device Description : Enthus Bite Registration, Regular Set, 2 x 50ml Cartridges & 6 Mixing Tips

Device Class :

Duns Number: 078444642

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

Enthus - 00353045001885 Catalog Number : 38-00012

Device Description : Enthus Bite Registration Fast Set, 2 x 50ml Cartridges & 6 Mixing Tips

Device Class :

Duns Number: 078444642

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

Jade - 00353045002127 Catalog Number : 20-00016

Device Description : Jade Blue 37% Phosphoric Acid Etchant Gel - 1 x 50ml Syringe & Instruction Insert

Device Class : 2

Duns Number: 078444642

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

Jade - 00353045002134 Catalog Number : 20-00091

Device Description : Jade Green 37% Phosphoric Acid Etchant Gel - 1 x 50ml Syringe & Instruction Insert

Device Class : 2

Duns Number: 078444642

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

Citrine - 00353045002349 Catalog Number : 56-00200

Device Description : Citrine 5% Sodium Fluoride Varnish, Spearmint Flavor - 50 x 0.4ml Unit-doses, 50 Citrine 5% Sodium Fluoride Varnish, Spearmint Flavor - 50 x 0.4ml Unit-doses, 50 Applicator Brushes, 1 Doctor Instruction Insert and 50 Patient Instruction Inserts

Device Class :

Duns Number: 078444642

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 50

Citrine - 00353045002356 Catalog Number : 56-00202

Device Description : Citrine 5% Sodium Fluoride Varnish, Vanilla Cake Flavor - 50 x 0.4ml Unit-doses, Citrine 5% Sodium Fluoride Varnish, Vanilla Cake Flavor - 50 x 0.4ml Unit-doses, 50 Applicator Brushes, 1 Doctor Instruction Insert and 50 Patient Instruction Inserts

Device Class :

Duns Number: 078444642

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 50

Citrine - 00353045002363 Catalog Number : 56-00204

Device Description : Citrine 5% Sodium Fluoride Varnish, Bubble Gum Flavor - 50 x 0.4ml Unit-doses, 5 Citrine 5% Sodium Fluoride Varnish, Bubble Gum Flavor - 50 x 0.4ml Unit-doses, 50 Applicator Brushes, 1 Doctor Instruction Insert and 50 Patient Instruction Inserts

Device Class :

Duns Number: 078444642

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 50

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