GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral Spray— 510(k) K181134

Clearance details

Applicant

Sunstar Americas, Inc.

Product code

Code LFD

Device class

Unclassified

Advisory panel

Unknown

Date received

2018-04-30

Decision date

2018-07-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Schaumburg, IL, US

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• K132325 — GUIDOR BIORESORBABLE MATRIX BARRIER2013-10-29
• K102053 — BUTLER CALCI-FLOR PROPHYLAXIS PASTE2011-02-03

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 →

• Z-1182-2021 — SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth.Class II·Terminated·Sunstar Americas, Inc.·20210218

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181134.