Sopix Inside, SOPIX2 Inside

FDA 510(k) K140013 · Sopro - Acteon Group

Substantially Equivalent

510(k) numberK140013

Submission

Device name
Sopix Inside, SOPIX2 Inside
Applicant
Sopro - Acteon Group
Mt Laurel, NJ, US
Received
January 2, 2014
Decision date
September 5, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
MUH – System, X-Ray, Extraoral Source, Digital
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1800
Specialty
Dental

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Questions and answers

When was Sopix Inside, SOPIX2 Inside cleared by the FDA?

Sopix Inside, SOPIX2 Inside (K140013) received a 510(k) decision of Substantially Equivalent on September 5, 2014, 246 days after the submission was received.

What is the product code of K140013?

The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.