Company · US
Sunstar Americas, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2018. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 13, 2018 | K181134 | GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral Spray Sunstar Americas, Inc. | LFD |
| Oct 29, 2013 | K132325 | GUIDOR BIORESORBABLE MATRIX BARRIER Sunstar Americas, Inc. | NPK |
| Feb 3, 2011 | K102053 | BUTLER CALCI-FLOR PROPHYLAXIS PASTE Sunstar Americas, Inc. | EJR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2022 | Sunstar Americas, Inc. BUTLER Clear Dip, 12 bottles/case Terminated |
OCT | None listed |
| May 21, 2021 | Sunstar Americas, Inc. 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 tee Terminated |
NTO | None listed |
| Mar 23, 2021 | Sunstar Americas, Inc. SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA Terminated |
EAX | None listed |
| Feb 18, 2021 | Sunstar Americas, Inc. 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 moistu Terminated |
LFD | K181134 |