Cleared Traditional

K253778 - Allday Moisturizing Rinse (FDA 510(k) Clearance)

Feb 2026
Decision
93d
Days
Risk

K253778 is an FDA 510(k) clearance for the Allday Moisturizing Rinse. This device is classified as a Saliva, Artificial.

Submitted by Elevate Oral Care (West Palm Beach, US). The FDA issued a Cleared decision on February 27, 2026, 93 days after receiving the submission on November 26, 2025.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K253778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2025
Decision Date February 27, 2026
Days to Decision 93 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LFD — Saliva, Artificial
Device Class