Quick Jet M

FDA 510(k) K133170 · Micron Corp.

Substantially Equivalent

510(k) numberK133170

Submission

Device name
Quick Jet M
Applicant
Micron Corp.
Ota-Ku, Tokyo, JP
Received
October 17, 2013
Decision date
March 28, 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
EFB – Handpiece, Air-Powered, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

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Questions and answers

When was Quick Jet M cleared by the FDA?

Quick Jet M (K133170) received a 510(k) decision of Substantially Equivalent on March 28, 2014, 162 days after the submission was received.

What is the product code of K133170?

The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.