Elevate Oral Care

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0658-2024Class IIIJust Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, ManufactureAugust 20, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K253778Allday Moisturizing RinseFebruary 27, 2026
K233768Papacarie DuoJuly 18, 2024
K222323Black DiamondJune 23, 2023
K150074Elevate Moisturizing SprayJune 19, 2015
K131376SMARTCOAT 2.5% NAF VARNISHAugust 27, 2013