K232917 is an FDA 510(k) clearance for the Chemo Mouthpiece. This device is classified as a Intraoral Cooling Device (Class II - Special Controls, product code QUA).
Submitted by Chemo Mouthpiece, LLC (Closter, US). The FDA issued a Cleared decision on January 23, 2024, 126 days after receiving the submission on September 19, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5590. 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.
| 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 |
| Product Code | QUA - Intraoral Cooling Device |
| Device Class | Class II - 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 |