Device Atlas

Clinpro Prophy Powder

Q: What is the product code of K140684?

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

FDA 510(k) K140684 · 3M Deutschland GmbH

Substantially Equivalent

510(k) numberK140684

Submission

Device name: Clinpro Prophy Powder
Applicant: 3M Deutschland GmbH
Bavaria D-82228 Seefeld, DE
Received: March 18, 2014
Decision date: October 24, 2014
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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K151748	Clean & MorePIP · Traditional	3M Deutschland GmbH	03/11/2016SE

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Questions and answers

When was Clinpro Prophy Powder cleared by the FDA?

Clinpro Prophy Powder (K140684) received a 510(k) decision of Substantially Equivalent on October 24, 2014, 220 days after the submission was received.

What is the product code of K140684?

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