510(k) K181134 · LFD Saliva, Artificial
GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral Spray
| Applicant | Sunstar Americas, Inc., Schaumburg IL, US |
| Decision | Substantially Equivalent, Jul 13, 2018 |
| Received | Apr 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181134
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.