Device |
handpiece, air-powered, root canal irrigation |
Regulation Description |
Dental handpiece and accessories. |
Definition |
To clean the root canal prior to filling and used for root canal irrigation. |
Physical State |
It is composed or aluminum, stainless steel and plastic |
Technical Method |
It is attached to the coupling for the dental handpiece and is used to provide irrigation solution into the root canal |
Target Area |
It is used to treat a tooth during a root canal procedure |
Regulation Medical Specialty |
Dental |
Review Panel |
Dental |
Product Code | NYL |
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 |
872.4200
|
Device Class |
1
|
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 Standards
|
Guidance Document
|
Third Party Review
|
Accredited Persons
|