Clean & More

FDA 510(k) K151748 · 3M Deutschland GmbH

Substantially Equivalent

510(k) numberK151748

Submission

Device name
Clean & More
Applicant
3M Deutschland GmbH
Seefeld, DE
Received
June 29, 2015
Decision date
March 11, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PIP – Prophy Powder, Airbrush Accessory
Device class
Class II (moderate risk)
Regulation
21 CFR 872.6080
Specialty
Dental

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

Other 510(k)s with product code PIP

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K140684Clinpro Prophy PowderPIP · Traditional 3M Deutschland GmbH10/24/2014SE

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Questions and answers

When was Clean & More cleared by the FDA?

Clean & More (K151748) received a 510(k) decision of Substantially Equivalent on March 11, 2016, 256 days after the submission was received.

What is the product code of K151748?

The FDA product code is PIP – Prophy Powder, Airbrush Accessory, a Class II (moderate risk) device regulated under 21 CFR 872.6080.