Scanwave Pen (with Light Gray Cord), Scanwave Pen (with Medium Gray Cord), Scanwave Pen (with Dark Gray Cord), Scanwave
FDA 510(k) K131906 · Satelec - Acteon Group
510(k) numberK131906
Submission
- Device name
- Scanwave Pen (with Light Gray Cord), Scanwave Pen (with Medium Gray Cord), Scanwave Pen (with Dark Gray Cord), Scanwave
- Applicant
- Satelec - Acteon Group
Mt. Laurel, NJ, US - Received
- June 26, 2013
- Decision date
- April 11, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Scanwave Pen (with Light Gray Cord), Scanwave Pen (with Medium Gray Cord), Scanwave Pen (with Dark Gray Cord), Scanwave cleared by the FDA?
Scanwave Pen (with Light Gray Cord), Scanwave Pen (with Medium Gray Cord), Scanwave Pen (with Dark Gray Cord), Scanwave (K131906) received a 510(k) decision of Substantially Equivalent on April 11, 2014, 289 days after the submission was received.
What is the product code of K131906?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.