DeviceClearance

Product code PIP— Dental

CLINPRO PROPHY POWDER

Classification name
Prophy Powder, Airbrush Accessory
Device class
Class 2
Regulation
21 CFR 872.6080
Advisory panel
Dental
Total cleared
2
First cleared
Most recent

FDA classification definition

“An air polishing powder to be used with an airbrush for prophylaxis in the oral cavity.”

— U.S. Food and Drug Administration, device classification record for product code PIP under 21 CFR 872.6080, via openFDA

Market context for product code PIP

FDA has cleared 2 devices under product code PIP between 2014 and 2016, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PIP

Recent clearances under product code PIP

Data sourced from openFDA. This site is unofficial and independent of the FDA.