Cleared Traditional

K232917 - Chemo Mouthpiece (FDA 510(k) Clearance)

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

K232917 · Chemo Mouthpiece, LLC · Dental device
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Optimized for regulatory review, auditing and printing
Jan 2024
Decision
126d
Days
Class 2
Risk

K232917 is an FDA 510(k) clearance for the Chemo Mouthpiece. Classified as Intraoral Cooling Device (product code QUA), Class II - Special Controls.

Submitted by Chemo Mouthpiece, LLC (Closter, US). The FDA issued a Cleared decision on January 23, 2024 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5590 - 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 Chemo Mouthpiece, LLC devices

Submission Details

510(k) Number K232917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2023
Decision Date January 23, 2024
Days to Decision 126 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
1d faster than avg
Panel avg: 127d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QUA Intraoral Cooling Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5590
Definition An Intraoral Cooling Device Is A Prescription Use Device That Is Intended To Cool The Mouth For Patients At Risk For Oral Mucositis. An Intraoral Cooling Device Consists Of A Removable Mouthpiece And Accessories That Cool Oral Mucosal Surfaces
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 Consultant

MCRA
Devjani Saha

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.