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Sunstar Americas, Inc.

FDA Regulatory Profile

Summary

Total Recalls
6 (1 Class I)
510(k) Clearances
3
Inspections
9
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0720-2022Class IIBUTLER Clear Dip, 12 bottles/caseJanuary 14, 2022
Z-1837-2021Class IISUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help pMay 21, 2021
Z-1382-2021Class IISUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PAMarch 23, 2021
Z-1182-2021Class IISUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product UFebruary 18, 2021
D-0222-2021Class IIParoex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pinDecember 28, 2020
D-0103-2021Class IParoex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pinOctober 27, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K181134G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral SpraJuly 13, 2018
K132325GUIDOR BIORESORBABLE MATRIX BARRIEROctober 29, 2013
K102053BUTLER CALCI-FLOR PROPHYLAXIS PASTEFebruary 3, 2011