Bluephase Style
FDA 510(k) K110756 · Ivoclar Vivadent, Inc.
510(k) numberK110756
Submission
- Device name
- Bluephase Style
- Applicant
- Ivoclar Vivadent, Inc.
Amherst, NY, US - Received
- March 18, 2011
- Decision date
- August 29, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Bluephase Style cleared by the FDA?
Bluephase Style (K110756) received a 510(k) decision of Substantially Equivalent on August 29, 2011, 164 days after the submission was received.
What is the product code of K110756?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.