FluoroCal
FDA 510(k) K182917 · Bisco, Inc.
510(k) numberK182917
Submission
- Device name
- FluoroCal
- Applicant
- Bisco, Inc.
Schaumburg, IL, US - Received
- October 19, 2018
- Decision date
- November 18, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K161051 | All-Bond Universal w/BAC (not finalized)KLE · Traditional | 09/09/2016SE |
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Questions and answers
When was FluoroCal cleared by the FDA?
FluoroCal (K182917) received a 510(k) decision of Substantially Equivalent on November 18, 2019, 395 days after the submission was received.
What is the product code of K182917?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.