FDA product code PIP: Prophy Powder, Airbrush Accessory
PIP is the FDA product code for prophy powder, airbrush accessory. It is a Class II device, regulated under 21 CFR 872.6080 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under PIP. The average 510(k) review took 238 days (median 238).
Definition
An air polishing powder to be used with an airbrush for prophylaxis in the oral cavity.
Classification
| Field | Value |
|---|---|
| Device name | Prophy Powder, Airbrush Accessory |
| Device class | Class II |
| Regulation | 21 CFR 872.6080 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every PIP clearance
Top PIP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| 3M Deutschland GmbH | 2 | 2016-03-11 |
Most recent PIP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K151748 | 3M Deutschland GmbH | Clean & More | 2016-03-11 | 256 |
| K140684 | 3M Deutschland GmbH | CLINPRO PROPHY POWDER | 2014-10-24 | 220 |
Recalls for PIP devices
openFDA lists no recalls for product code PIP.
Frequently asked questions
What is FDA product code PIP?
PIP is the FDA product code for prophy powder, airbrush accessory. It is a Class II device, regulated under 21 CFR 872.6080 and reviewed by the Dental panel.
What device class is PIP?
Class II, regulation 21 CFR 872.6080. Typical premarket route: 510(k).
How long does a 510(k) take for product code PIP?
Across 2 cleared submissions the average was 238 days from receipt to decision (median 238).
Which companies have the most PIP clearances?
3M Deutschland GmbH (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PIP
- Run a recall and safety report across every PIP manufacturer
- Watch product code PIP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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