Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist— 510(k) K173237

Name: FDA 510(k) clearance K173237
Creator: U.S. Food and Drug Administration
Published: 2018-03-19

Substantially Equivalent

Syendgen, Inc.

FDA 510(k) clearance K173237 for Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist, Substantially Equivalent on 2018-03-19. Applicant: Syendgen, Inc.. Device class: Unclassified.

Clearance details

Applicant: Syendgen, Inc.
Product code: Code LFD
Device class: Unclassified
Advisory panel: Unknown
Date received: 2017-10-05
Decision date: 2018-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Claremont, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFD

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K240508 — Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)2024-04-19
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

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.