Device Type ID | 1289 |
Device Name | Airbrush |
Regulation Description | Airbrush. |
Regulation Medical Specialty | Dental |
Review Panel | Dental |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
Submission Type | 510(k) |
CFR Regulation Number | 872.6080 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | KOJ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
Device Type ID | 1289 |
Device | Airbrush |
Product Code | KOJ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Airbrush. |
CFR Regulation Number | 872.6080 [🔎] |
Device Problems | |
---|---|
Excess Flow Or Over-Infusion | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Operates Differently Than Expected | 1 |
Total Device Problems | 3 |