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QTT — Over The Counter Electrical Salivary Stimulatory System Class II

FDA Device Classification

Classification Details

Product Code
QTT
Device Class
Class II
Regulation Number
872.5560
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Definition

Over the Counter Device intended to electrically stimulate a relative increase in saliva production

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232063saliwellSaliPenDecember 13, 2023
K220618saliwellSaliPenAugust 30, 2022