510(k) Report

FDA applicant

Elevate Oral Care

West Palm Beach, FL5 decisions2013–20260 recalls

FDA records 5 decisions for Elevate Oral Care (West Palm Beach, FL) from 2013 to 2026: 5 510(k) clearances. Most are in product codes LFD (Saliva, Artificial) and LBH (Varnish, Cavity). Its devices cite 8 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Elevate Oral Care, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Elevate Oral Care’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2013: 12015: 12023: 12024: 12026 (partial year): 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Elevate Oral Care by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Elevate Oral Care’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LFDSaliva, Artificial2decisions
  • LBHVarnish, Cavity2decisions
  • PHRDiammine Silver Fluoride Dental Hypersensitivity Varnish1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K150074Elevate Moisturizing SprayElevate Oral Care · 20151cites it
  • K131376Smartcoat 2.5% Naf VarnishElevate Oral Care · 20131cites it

What has FDA decided for it lately?

  • K253778Allday Moisturizing RinseElevate Oral Care · 2026
  • K233768Papacarie DuoElevate Oral Care · 2024
  • K222323Black DiamondElevate Oral Care, LLC · 2023
  • K150074Elevate Moisturizing SprayElevate Oral Care · 2015
  • K131376Smartcoat 2.5% Naf VarnishElevate Oral Care · 2013

All 4 as Elevate Oral Care →The one decision as Elevate Oral Care, LLC →

Other applicant names beginning “Elevate”

FDA records each applicant name separately; these may or may not be the same firm.

Elevate Textiles 1