ELEVATE ORAL CARE, LLC

Matched from indexed company URL: ELEVATE ORAL CARE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30096031513009603151ELEVATE ORAL CARE, LLC1N2026-01-01346 Pike Rd Ste 1 5 13 & 23 West Palm Beach FL US 33411

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00858290006802Advantage Arrest - Advantage Arrest Silver Diamine Fluoride 38% GEL Unit Dose Ampoule with applicators 30pk877-866-9113info@elevateoralcare.com
00858290006819Advantage Arrest - Advantage Arrest Silver Diamine Fluoride 38% GEL Unit Dose Ampoule with applicators 50pk Spanish877-866-9113info@elevateoralcare.com
00858290006826Advantage Arrest - Advantage Arrest Silver Diamine Fluoride 38% GEL Unit Dose Ampoule with applicators 50pk Spanish877-866-9113info@elevateoralcare.com
00858290006956Advantage Arrest - Advantage Arrest SDF 38% Gel Syringe 2.8ml Kit877-866-9113info@elevateoralcare.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1424641502185003K895386GLASIONEMA1990-04-16
1424641040953645K850915WAX BITE IMPRESSION WAFEREGD1985-04-16
1424641408977724K233768Papacarie DuoLBH2024-07-18
1424641451634556K201785EPIEN Dental CleanserKJJ2021-09-09
1424641224762072K150074Elevate Moisturizing SprayLFD2015-06-19
1424641968319703K131376SMARTCOAT 2.5% NAF VARNISHLBH2013-08-27
1424641945188330K123538EPIEN ROOT CANAL CLEANSERKJJ2013-02-01
1424641125568879K102973SILVER DENTAL ARRESTPHR2014-07-31
1424641665344651K093059SELECT DEFENSE DENTAL PIT AND FISSURE SEALANTEBC2010-02-04
1424641769785464K080445LION SE ONE STEP ORTHODONTIC ADHESIVEDYH2008-07-16
1424641855763827
1424641489915819
1424641873387023

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LBH22024-07-18
KJJ22021-09-09
LFD12015-06-19
PHR12014-07-31
EBC12010-02-04
DYH12008-07-16
EMA11990-04-16
EGD11985-04-16

NDC#

Allday 5000

Elevate Oral Care

1.1% Sodium Fluoride Toothpaste

Stance

Elevate Oral Care

0.63% Stannous Fluoride Concentrate Rinse

Stance

Elevate Oral Care

0.63% Stannous Fluoride Concentrate Rinse

Povi-One

Elevate Oral Care

Povidone-Iodine 10% Topical

Povi-One

Elevate Oral Care

Povidone-Iodine 10% topical

PMN#

GUDID#

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