510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180838Substantially Equivalent

SaliPen

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

K180838 is the FDA 510(k) clearance record for SaliPen, a class II device, cleared for Saliwell , Ltd. on under FDA product code LTF (Stimulator, Salivary System). FDA records list 4 510(k) clearances for Saliwell , Ltd., from to . As of , FDA records show no recalls naming K180838.

Clearance record

Decision date
Received
(221 days to decision)
Product code
LTF Stimulator, Salivary System
Regulation
21 CFR 872.5560
Device class
Class II
Review panel
Dental
Applicant
Saliwell , Ltd. 65 Hatamar St., Harutzim, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LTF

Trailing 12 months

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

FDA records show no clearances under product code LTF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LTF, 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