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

Varnish, Cavity (LBH) (5) Wax, Dental, Intraoral (EGD) (2) Cement, Dental (EMA) (1) Diammine Silver Fluoride Dental Hypersensitivity Varnish (PHR) (1) Scraper, Tongue (LCN) (1)

Premarket Exempt

No Yes

Clear

Advantage Arrest - 00858290006130 Catalog Number :

Device Description : Advantage Arrest Silver Diamine Fluoride 38% Unit Dose Ampoule with applicators 30pk

Device Class :

Duns Number: 002863526

Premarket Exempt : No

Product Code : PHR

Prescription Use : Yes

Device Count : 30

FluoriMax 2.5% NaF Varnish Through - 00858290006147 Catalog Number :

Device Description : FluoriMax 2.5% NaF Varnish Through Mint Ampoule

Device Class : 2

Duns Number: 002863526

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

FluoriMax 2.5% NaF Varnish Flow Through - 00858290006154 Catalog Number :

Device Description : FluoriMax 2.5% NaF Varnish Flow Through BG Foil Pk

Device Class : 2

Duns Number: 002863526

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

FluoriMax Salted Caramel - 00858290006215 Catalog Number : 530CM1018

Device Description : FluoriMax 2.5% NaF Varnish Salted CARAMEL Flavor Labeled Bottle

Device Class :

Duns Number: 002863526

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

FluoriMax 2.5% NaF Varnish Flow Through - 00858290006222 Catalog Number :

Device Description : FluoriMax 2.5% NaF Varnish Flow Through Salted Caramel Foil Pk

Device Class :

Duns Number: 002863526

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

Elevate Tongue Cleaner Metal - 00858290006277 Catalog Number :

Device Description : Elevate Tongue Cleaner Metal

Device Class : 1

Duns Number: 002863526

Premarket Exempt : Yes

Product Code : LCN

Prescription Use : No

Device Count : 1

Toothprint Wafer - 00858290006284 Catalog Number :

Device Description : Toothprint Wafer Kit-48pk

Device Class :

Duns Number: 002863526

Premarket Exempt : No

Product Code : EGD

Prescription Use : Yes

Device Count : 48

FluoriMax 2.5% NaF demo pack - 00858290006307 Catalog Number :

Device Description : FluoriMax 2.5% NaF FMFT demo pack

Device Class : 2

Duns Number: 002863526

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 1

Tooth Print Wafer Sample Pack - 00858290006314 Catalog Number :

Device Description : Tooth Print Wafer Sample Pack

Device Class : 1

Duns Number: 002863526

Premarket Exempt : No

Product Code : EGD

Prescription Use : No

Device Count : 1

PAA Tooth Conditioner - 00858290006321 Catalog Number :

Device Description : PAA Tooth Conditioner Filled & Labeled 15 ml Bottle Kit

Device Class : 2

Duns Number: 002863526

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

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