510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QTTClass II

Over The Counter Electrical Salivary Stimulatory System

21 CFR 872.5560 / Dental
FDA source (opens on fda.gov)

QTT is the FDA product code for Over The Counter Electrical Salivary Stimulatory System, a class II device type, regulated under 21 CFR 872.5560. FDA's definition for this code reads: "Over the Counter Device intended to electrically stimulate a relative increase in saliva production". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QTT
Device name
Over The Counter Electrical Salivary Stimulatory System
FDA definition
Over the Counter Device intended to electrically stimulate a relative increase in saliva production
Regulation
21 CFR 872.5560
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QTT

By decision year
2 clearances under product code QTT with a decision year between 2022 and 2023, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QTT by decision year
YearClearances
20221
20231

Applicants with the most clearances

Product code QTT
Applicants holding the most 510(k) clearances under product code QTT
ApplicantClearances
Saliwell Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code