ELEVATE ORAL CARE, LLC

Address:346 Pike Rd Ste 1, 5, 13, & 23,West Palm Beach,FL,33411,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) (4) Sealant, Pit And Fissure, And Conditioner (EBC) (4) Adhesive, Bracket And Tooth Conditioner, Resin (DYH) (2)

Premarket Exempt

No Yes

Clear

Smart Advantage GI A1 and A2 Combo kit 30 ampules - 00858290006352 Catalog Number :

Device Description : Smart Advantage GI A1 and A2 Combo kit 30 ampules

Device Class :

Duns Number: 002863526

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Smart Advantage GI A1 ampule - 00858290006369 Catalog Number :

Device Description : Smart Advantage GI A1 ampule

Device Class :

Duns Number: 002863526

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Smart Advantage GI A2 ampoule - 00858290006376 Catalog Number :

Device Description : Smart Advantage GI A2 ampoule

Device Class :

Duns Number: 002863526

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Smart Advantage GI Sample A1 and A2 pk - 00858290006444 Catalog Number :

Device Description : Smart Advantage GI Sample A1 and A2 pk

Device Class :

Duns Number: 002863526

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

DenteShield Pit and Fissure Sealant Kit with Fluoride Clear - 00858290006529 Catalog Number :

Device Description : DenteShield Pit and Fissure Sealant Kit with Fluoride Clear

Device Class : 2

Duns Number: 002863526

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 1

DenteShield Pit and Fissure Sealant Kit with Fluoride Opaque - 00858290006536 Catalog Number :

Device Description : DenteShield Pit and Fissure Sealant Kit with Fluoride Opaque

Device Class : 2

Duns Number: 002863526

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 1

Denteshield Primer 3ml Kit - 00858290006543 Catalog Number :

Device Description : Denteshield Primer 3ml Kit

Device Class : 2

Duns Number: 002863526

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Denteshield Primer 7ml Kit - 00858290006550 Catalog Number :

Device Description : Denteshield Primer 7ml Kit

Device Class : 2

Duns Number: 002863526

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

DenteShield Surface Sealant 3ml Kit - 00858290006567 Catalog Number :

Device Description : DenteShield Surface Sealant 3ml Kit

Device Class : 2

Duns Number: 002863526

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 1

DenteShield Surface Sealant 7ml Kit - 00858290006574 Catalog Number :

Device Description : DenteShield Surface Sealant 7ml Kit

Device Class : 2

Duns Number: 002863526

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 1

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