Device |
prophy powder, airbrush accessory |
Regulation Description |
Airbrush. |
Definition |
An air polishing powder to be used with an airbrush for prophylaxis in the oral cavity. |
Physical State |
Powder |
Technical Method |
The powder is dispensed via an electric airbrush and removes plaque via abrasion of the tooth surface by the powder granules. |
Target Area |
Oral cavity |
Regulation Medical Specialty |
Dental |
Review Panel |
Dental |
Product Code | PIP |
Premarket Review |
Division of Dental and ENT Devices
(DHT1B)
Division of Dental and ENT Devices
(DHT1B)
|
Submission Type |
510(k)
|
Regulation Number |
872.6080
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standard
|
Third Party Review
|
Accredited Persons
|