Oral-B Dry Mouth Oral Rinse— 510(k) K203567

Name: FDA 510(k) clearance K203567
Creator: U.S. Food and Drug Administration
Published: 2021-04-05

Substantially Equivalent

The Procter & Gamble Company

FDA 510(k) clearance K203567 for Oral-B Dry Mouth Oral Rinse, Substantially Equivalent on 2021-04-05. Applicant: The Procter & Gamble Company. Device class: Unclassified.

Clearance details

Applicant: The Procter & Gamble Company
Product code: Code LFD
Device class: Unclassified
Advisory panel: Unknown
Date received: 2020-12-07
Decision date: 2021-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, 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
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

More clearances from The Procter & Gamble Company

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K201277 — Oral-B Dry Mouth Oral Rinse2020-09-02
K200881 — Oral-B iO Test Drive Power Brush Trial Program Kit2020-08-27
K133244 — TAMPAX M PLASTIC TAMPONS, UNSCENTED2014-01-09
K113699 — TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED2012-01-12

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.