Cleared Traditional

K232063 - SaliPen (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232063 · Saliwell , Ltd. · Dental device
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Dec 2023
Decision
155d
Days
Class 2
Risk

K232063 is an FDA 510(k) clearance for the SaliPen. Classified as Over The Counter Electrical Salivary Stimulatory System (product code QTT), Class II - Special Controls.

Submitted by Saliwell , Ltd. (Harutzim, IL). The FDA issued a Cleared decision on December 13, 2023 after a review of 155 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5560 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Saliwell , Ltd. devices

Submission Details

510(k) Number K232063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2023
Decision Date December 13, 2023
Days to Decision 155 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 127d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QTT Over The Counter Electrical Salivary Stimulatory System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5560
Definition Over The Counter Device Intended To Electrically Stimulate A Relative Increase In Saliva Production
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - QTT Over The Counter Electrical Salivary Stimulatory System

Devices cleared under the same product code (QTT) and FDA review panel - the closest regulatory comparables to K232063.
SaliPen
K220618 · Saliwell , Ltd. · Aug 2022