Allday Moisturizing Rinse— 510(k) K253778
Substantially EquivalentElevate Oral Care
FDA 510(k) clearance K253778 for Allday Moisturizing Rinse, Substantially Equivalent on 2026-02-27. Applicant: Elevate Oral Care. Device class: Unclassified.
Summary
Elevate Oral Care's Allday Moisturizing Rinse is filed under product code LFD, artificial saliva. The record says nothing more about the product than its name and that code name.
Class U, with no regulation number. The classification panel is listed as Unknown, and the Dental review panel handled it as a Traditional 510(k).
Elevate Oral Care filed from West Palm Beach, Florida. The substantially equivalent decision came 93 calendar days after receipt (November 26, 2025 to February 27, 2026).
Clearance details
- Applicant
- Elevate Oral Care
- Product code
- Product code LFD
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Palm Beach, FL, US
Recent devices under product code LFD
view allMore clearances from Elevate Oral Care
view allAdverse events under product code LFD
product code LFD- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.