Device |
intraoral cooling device |
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 |
Physical State |
A removable mouthpiece that contains a liquid or solid coolant at freezing or near freezing temperatures |
Technical Method |
The mouthpiece exhibits cooling technology that allows for heat transfer between the mouthpiece and the oral mucosa thereby cooling the oral mucosa |
Target Area |
Oral Mucosa in the mouth |
Regulation Medical Specialty |
Dental |
Review Panel |
Dental |
Product Code | QUA |
Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
Submission Type |
510(k)
|
Regulation Number |
872.5590
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |