Sunstar Americas, Inc.
Sunstar Americas, Inc. holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2018, with 4 FDA device recalls on record.
Top product codes for Sunstar Americas, Inc.
FDA recalls by Sunstar Americas, Inc.
- Z-0720-2022 — BUTLER Clear Dip, 12 bottles/case
- Z-1837-2021 — SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.
- Z-1382-2021 — SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Sunstar Americas, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.