Data / Medical devices / United States / Elevate Oral Care, LLC

Elevate Oral Care, LLC: FDA-registered device maker in West Palm Beach, FL, United States, 7 510(k) clearances

Name: Elevate Oral Care, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Elevate Oral Care, LLC is registered with the FDA (registration 3009603151) in West Palm Beach, FL, United States. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated February 27, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3009603151
Address: 346 Pike Rd Ste 1 5 13 & 23, West Palm Beach, FL, United States, 33411
Owner or operator: Elevate Oral Care (10041046)
Roles: Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
First device listed: September 15, 2014
Registered through: 2027
Brand names listed: Advantage Arrest, Advantage Arrest Gel, Advantage Arrest Silver Diamine Fluoride 38% and FluoriMax 2.5% Sodium Fluoride Varnish Convenience Kit, Advantage Arrest Unit Dose, Allday Dry Mouth Gel, Allday Dry Mouth Spray, Allday Oral Moisturizing Rinse, Epic Tongue Cleaner and more

Devices it lists

Device	Product code	Class	Role	Source
Agent, Tooth Bonding, Resin	KLE	2	Specification developer	accessdata.fda.gov
Cleanser, Root Canal	KJJ	U	Repackager or relabeler	accessdata.fda.gov
Diammine Silver Fluoride Dental Hypersensitivity Varnish	PHR	2	Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Saliva, Artificial	LFD	U	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Scraper, Tongue	LCN	1	Repackager or relabeler	accessdata.fda.gov
Varnish, Cavity	LBH	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 27, 2026	K253778	Allday Moisturizing Rinse	LFD	Substantially Equivalent	Elevate Oral Care	accessdata.fda.gov
July 18, 2024	K233768	Papacarie Duo	LBH	Substantially Equivalent	Elevate Oral Care	accessdata.fda.gov
September 9, 2021	K201785	EPIEN Dental Cleanser	KJJ	Substantially Equivalent	Epien Medical, Inc.	accessdata.fda.gov
June 19, 2015	K150074	Elevate Moisturizing Spray	LFD	Substantially Equivalent	Elevate Oral Care	accessdata.fda.gov
July 31, 2014	K102973	SILVER DENTAL ARREST	PHR	Substantially Equivalent	Cooley Consulting, Inc.	accessdata.fda.gov
August 27, 2013	K131376	SMARTCOAT 2.5% NAF VARNISH	LBH	Substantially Equivalent	Elevate Oral Care	accessdata.fda.gov
February 1, 2013	K123538	EPIEN ROOT CANAL CLEANSER	KJJ	Substantially Equivalent	Epien Medical, Inc.	accessdata.fda.gov

Compare with other makers

Updated February 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.