Optiglaze Color
FDA 510(k) K133836 · GC America, Inc.
510(k) numberK133836
Submission
- Device name
- Optiglaze Color
- Applicant
- GC America, Inc.
Alsip, IL, US - Received
- December 18, 2013
- Decision date
- March 6, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Optiglaze Color cleared by the FDA?
Optiglaze Color (K133836) received a 510(k) decision of Substantially Equivalent on March 6, 2014, 78 days after the submission was received.
What is the product code of K133836?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.