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

Saliva, Artificial (LFD) (4) Diammine Silver Fluoride Dental Hypersensitivity Varnish (PHR) (3) Scraper, Tongue (LCN) (2) Sealant, Pit And Fissure, And Conditioner (EBC) (1)

Premarket Exempt

No Yes

Clear

DenteShield Sample Opaque with Fluoride - 00858290006598 Catalog Number :

Device Description : DenteShield Sample Opaque with Fluoride

Device Class : 2

Duns Number: 002863526

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 1

Advantage Arrest - 00858290006604 Catalog Number :

Device Description : Advantage Arrest Silver Diamine Fluoride 38% 3 ml dropper bottle-3 pack

Device Class : 2

Duns Number: 002863526

Premarket Exempt : No

Product Code : PHR

Prescription Use : Yes

Device Count : 1

Advantage Arrest - 00858290006611 Catalog Number : 635000030

Device Description : Advantage Arrest Silver Diamine Fluoride 38% 3 ml dropper bottle

Device Class : 2

Duns Number: 002863526

Premarket Exempt : No

Product Code : PHR

Prescription Use : Yes

Device Count : 1

Advantage Arrest - 00858290006628 Catalog Number : 635IN5000

Device Description : Advantage Arrest Silver Diamine Fluoride 38% 50 pk ampoule

Device Class : 2

Duns Number: 002863526

Premarket Exempt : No

Product Code : PHR

Prescription Use : Yes

Device Count : 50

Allday Gel 2 pk - 00858290006635 Catalog Number :

Device Description : Allday Gel 2 pk

Device Class : U

Duns Number: 002863526

Premarket Exempt : No

Product Code : LFD

Prescription Use : No

Device Count : 1

Elevate Tongue Cleaner Metal Green w/Pink and Blue Bands - 00858290006642 Catalog Number :

Device Description : Elevate Tongue Cleaner Metal Green w/Pink and Blue Bands

Device Class : 1

Duns Number: 002863526

Premarket Exempt : Yes

Product Code : LCN

Prescription Use : No

Device Count : 1

Elevate Tongue Cleaner Metal 6pk - 00858290006659 Catalog Number :

Device Description : Elevate Tongue Cleaner Metal 6pk

Device Class : 1

Duns Number: 002863526

Premarket Exempt : Yes

Product Code : LCN

Prescription Use : No

Device Count : 1

Allday Spray 2 pk - 00858290006666 Catalog Number :

Device Description : Allday Spray 2 pk

Device Class : U

Duns Number: 002863526

Premarket Exempt : No

Product Code : LFD

Prescription Use : No

Device Count : 1

Allday Spray - 00858290006703 Catalog Number :

Device Description : AllDay Spray Pillow Box Kit - 1.5oz Bottle

Device Class : U

Duns Number: 002863526

Premarket Exempt : No

Product Code : LFD

Prescription Use : No

Device Count : 1

Allday GEL - 00858290006710 Catalog Number :

Device Description : AllDay Gel Pillow Box Kit - 1.5oz Tube

Device Class : U

Duns Number: 002863526

Premarket Exempt : No

Product Code : LFD

Prescription Use : No

Device Count : 1

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