Vip- Variable Intensity Polymerizer
FDA 510(k) K000426 · Bisco, Inc.
510(k) numberK000426
Submission
- Device name
- Vip- Variable Intensity Polymerizer
- Applicant
- Bisco, Inc.
Schaumburg, IL, US - Received
- February 9, 2000
- Decision date
- April 12, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Vip- Variable Intensity Polymerizer cleared by the FDA?
Vip- Variable Intensity Polymerizer (K000426) received a 510(k) decision of Substantially Equivalent on April 12, 2000, 63 days after the submission was received.
What is the product code of K000426?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.