Last synced on 19 July 2024 at 11:05 pm

Intraoral Cooling Device

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.5590
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QUA is linked to regulation 21CFR872.5590, which does not seem to exist yet. It may be pending at the moment.

Intraoral Cooling Device

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.5590
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QUA is linked to regulation 21CFR872.5590, which does not seem to exist yet. It may be pending at the moment.