Cleared Traditional

K240508 - Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) (FDA 510(k) Clearance)

Apr 2024
Decision
58d
Days
-
Risk

K240508 is an FDA 510(k) clearance for the Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel). This device is classified as a Saliva, Artificial.

Submitted by Laclede, Inc. (Rancho Dominguez, US). The FDA issued a Cleared decision on April 19, 2024, 58 days after receiving the submission on February 21, 2024.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K240508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2024
Decision Date April 19, 2024
Days to Decision 58 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LFD - Saliva, Artificial
Device Class -