Ios Fastscan Spray

FDA 510(k) K103586 · Ios Technnologies, Inc.

Substantially Equivalent

510(k) numberK103586

Submission

Device name
Ios Fastscan Spray
Applicant
Ios Technnologies, Inc.
San Diego, CA, US
Received
December 7, 2010
Decision date
March 30, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ELW – Material, Impression
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3660
Specialty
Dental

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Questions and answers

When was Ios Fastscan Spray cleared by the FDA?

Ios Fastscan Spray (K103586) received a 510(k) decision of Substantially Equivalent on March 30, 2011, 113 days after the submission was received.

What is the product code of K103586?

The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.