Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2013-10-17 | Z-0272-2014 | Class II | Terminated | Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.Distribution: Nationwide Distribution . | 483,204 bottles | clearance family |
- 510(k)K123731Substantially equivalent (SESE) · 2013-01-04clearance family
Predicate lineage
Cited as predicate by: K150074, K152201, K163029, K181134, K181194, K181839, K231205, K240508, K253778
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
None in the loaded window.
- 3M™ ESPE™ 3M COMPANY
- 3M™ ESPE™ 3M COMPANY
- 3M™ ESPE™ 3M COMPANY
- Allday GEL ELEVATE ORAL CARE, LLC
- Allday Gel 2 pk ELEVATE ORAL CARE, LLC
- Allday Oral Moisturizing Rinse, 10oz Bottle ELEVATE ORAL CARE, LLC
- Allday Spray ELEVATE ORAL CARE, LLC
- Allday Spray 2 pk ELEVATE ORAL CARE, LLC
- Allday Spray 4 pk ELEVATE ORAL CARE, LLC
- Allday Spray/Gel Sample Bag ELEVATE ORAL CARE, LLC
- BioXtra ORABIO, INC.
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED