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
K232063Substantially Equivalent

SaliPen

Saliwell Ltd., Harutzim, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232063 is the FDA 510(k) clearance record for SaliPen, a class II device, cleared for Saliwell , Ltd. on under FDA product code QTT (Over The Counter Electrical Salivary Stimulatory System). FDA's definition for product code QTT reads: "Over the Counter Device intended to electrically stimulate a relative increase in saliva production". FDA records list 4 510(k) clearances for Saliwell , Ltd., from to . As of , FDA records show no recalls naming K232063.

Clearance record

Decision date
Received
(155 days to decision)
Product code
QTT Over The Counter Electrical Salivary Stimulatory System
Regulation
21 CFR 872.5560
Device class
Class II
Review panel
Dental
Applicant
Saliwell , Ltd. 3a Hatamar St., Harutzim, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QTT

Trailing 12 months

FDA records hold no clearances under product code QTT in the trailing twelve months.

FDA records show no clearances under product code QTT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QTT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260