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

K240508 is an FDA 510(k) clearance for the Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel). Classified as Saliva, Artificial (product code LFD).

Submitted by Laclede, Inc. (Rancho Dominguez, US). The FDA issued a Cleared decision on April 19, 2024 after a review of 58 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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