Cleared Traditional

Allday Moisturizing Rinse

K253778 · Elevate Oral Care · Dental
Feb 2026
Decision
93d
Days
—
Risk

About This 510(k) Submission

K253778 is an FDA 510(k) clearance for the Allday Moisturizing Rinse, 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 review panel.

Submission Details

510(k) Number K253778 FDA.gov
FDA Decision Cleared 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 —

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