Manufacturer registered with FDA
Elevate Oral Care
West Palm Beach, FL, United States. Lists 4 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 8
- 510(k) clearances
- 32013–2024
- Markets registered in
- 46 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Elevate Oral Care as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Elevate Oral Care | 3 clearances | 2013–2024 | Below |
| European Union | EUDAMED | Manufacturer | Elevate Oral Care, LLC | 2 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | elevate oral care, LLC | 2 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Elevate Oral Care, LLC | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Elevate Oral Care currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | FluoriMaxPapaCarie Duo | 2014 |
| Diammine Silver Fluoride Dental Hypersensitivity VarnishPHR · Class 2 | — | Maker | Advantage ArrestAdvantage Arrest GelAdvantage Arrest Silver Diamine Fluoride 38% and FluoriMax 2.5% Sodium Fluoride Varnish Convenience KitAdvantage Arrest Unit Dose | 2015 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | PapaCarie Duo | 2024 |
| Tongue ScraperLCN · Class 1 | — | Lister | Epic Tongue Cleaner | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Elevate Oral Care as the applicant.
Also lists devices cleared under other names
Elevate Oral Care lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Cooley Consulting, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 31 Jul 2014 | K102973 | SILVER DENTAL ARREST | Cooley Consulting, Inc. | PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ELEVATE ORAL CARE, LLCFDA reg. 3009603151 | West Palm Beach, FL, United States | Complaint file establishment, Manufacturer, Remanufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10041046). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.