Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)— 510(k) K240508

Name: FDA 510(k) clearance K240508
Creator: U.S. Food and Drug Administration
Published: 2024-04-19

Substantially Equivalent

Laclede, Inc.

FDA 510(k) clearance K240508 for Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel), Substantially Equivalent on 2024-04-19. Applicant: Laclede, Inc.. Device class: Unclassified.

Clearance details

Applicant: Laclede, Inc.
Product code: Code LFD
Device class: Unclassified
Advisory panel: Unknown
Date received: 2024-02-21
Decision date: 2024-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Dominguez, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFD

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K253778 — Allday Moisturizing Rinse2026-02-27
K250390 — CloSYS® Dry Mouth Sensitive Mouth Rinse2025-05-19
K234015 — Caphosol® Artifical Saliva (32 doses sachet box)2024-03-11
K231205 — GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray2023-08-22
K202689 — Dentilube Spray2021-09-03

More clearances from Laclede, Inc.

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K180680 — Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray2018-10-11
K162235 — LUVENA VAGINAL MOISTURIZER & LUBRICANT2017-03-24
K150841 — Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant2015-12-29
K061331 — ORAL BALANCE LIQUID/ GEL2006-07-25

Adverse events under product code LFD

product code LFD

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.