GC Blue Silicone

FDA 510(k) K120521 · GC America, Inc.

Substantially Equivalent

510(k) numberK120521

Submission

Device name
GC Blue Silicone
Applicant
GC America, Inc.
Alsip, IL, US
Received
February 21, 2012
Decision date
May 10, 2012
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 GC Blue Silicone cleared by the FDA?

GC Blue Silicone (K120521) received a 510(k) decision of Substantially Equivalent on May 10, 2012, 79 days after the submission was received.

What is the product code of K120521?

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