Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009603151

FEI Number

3009603151

Entity Name

ELEVATE ORAL CARE, LLC

City/State/Country

West Palm Beach, FL, US

Establishment Address

346 Pike Rd Ste 1 5 13 & 23, West Palm Beach, FL 33411, US

Establishment Type(s)

Repack or Relabel Medical Device,Remanufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Elevate Oral Care (Owner Number: 10041046)

Owner / Operator Contact Address

346 Pike Road, Suite 1, 5, 13, & 23, West Palm Beach, FL 33411, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102973

PMA Number

N/A

All Registered Proprietary Names

Epic Tongue Cleaner Allday Dry Mouth Spray Allday Dry Mouth Gel Hybenx FluoriMax Advantage Arrest Advantage Arrest Unit Dose Advantage Arrest Gel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2015-03-12
LFD	Saliva, Artificial	Unknown	Class U	N/A	2018-09-12
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2026-03-02
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2014-09-15
PHR	Diammine Silver Fluoride Dental Hypersensitivity Varnish	Dental	Class 2	872.3260	2015-04-22

Official Correspondent

Teri Sturgell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Elevate Oral Care

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033295	Novamin Technology, Inc.	BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN	2003-10-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2020	Inter-Med Llc	U	Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
Z-0012-2020	Inter-Med Llc	U	Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Z-0013-2020	Inter-Med Llc	U	Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
Z-0014-2020	Inter-Med Llc	U	Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
Z-0015-2020	Inter-Med Llc	U	Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009603151. Last updated year: 2026. Please use registration number 3009603151 when referencing this establishment in official correspondence.