Definition: An Air Polishing Powder To Be Used With An Airbrush For Prophylaxis In The Oral Cavity.
| Device Type ID | 1380 |
| Device Name | Prophy Powder, Airbrush Accessory |
| 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 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 | PIP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1380 |
| Device | Prophy Powder, Airbrush Accessory |
| Product Code | PIP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Airbrush. |
| CFR Regulation Number | 872.6080 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
3M COMPANY, 3M HEALTH CARE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |