DeviceClearance

Product code QTT— Dental

SaliPen

Classification name
Over The Counter Electrical Salivary Stimulatory System
Device class
Class 2
Regulation
21 CFR 872.5560
Advisory panel
Dental
Total cleared
2
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code QTT under 21 CFR 872.5560, via openFDA

Market context for product code QTT

FDA has cleared 2 devices under product code QTT between 2022 and 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QTT

Recent clearances under product code QTT

Data sourced from openFDA. This site is unofficial and independent of the FDA.