510(k) K123731 ยท LFD Saliva, Artificial
BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
| Applicant | Glaxosmithkline Consumer Healthcare (Gskch), Parsippany NJ, US |
| Decision | Substantially Equivalent, Jan 4, 2013 |
| Received | Dec 5, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123731
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2013 | GlaxoSmithKline, LLC. Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Towns Terminated |
LFD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.