Consumer health companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Elevate Oral Care with 5 510(k) clearances and 2 drug recalls. The most recent is a drug recall dated Jun 4, 2026: Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 P….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 4, 2026 | Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57Class II · sub potency | Drug recalls |
| Feb 27, 2026 | Allday Moisturizing RinseK253778 · LFD | 510(k) clearances |
| Aug 20, 2024 | Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.Class III · LABELING: LABEL MIX-UP. | Drug recalls |
| Jul 18, 2024 | Papacarie DuoK233768 · LBH | 510(k) clearances |
| Jun 23, 2023 | Black DiamondK222323 · PHR | 510(k) clearances |
| Jun 19, 2015 | Elevate Moisturizing SprayK150074 · LFD | 510(k) clearances |
| Aug 27, 2013 | SMARTCOAT 2.5% NAF VARNISHK131376 · LBH | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
