Cleared Traditional

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

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

K253778 is an FDA 510(k) clearance for the Allday Moisturizing Rinse. Classified as Saliva, Artificial (product code LFD).

Submitted by Elevate Oral Care (West Palm Beach, US). The FDA issued a Cleared decision on February 27, 2026 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Elevate Oral Care devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 127d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 49
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K253778.
CloSYS® Dry Mouth Sensitive Mouth Rinse
K250390 · Rowpar Pharmaceuticals, Inc. · May 2025
Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
K240508 · Laclede, Inc. · Apr 2024
Caphosol® Artifical Saliva (32 doses sachet box)
K234015 · Eusa Pharma (Uk) Limited · Mar 2024
GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
K231205 · Gurunanda, LLC · Aug 2023
Dentilube Spray
K202689 · Oxy2plus, LLC · Sep 2021
Oral-B Dry Mouth Oral Rinse
K203567 · The Procter & Gamble Company · Apr 2021