510(k) K131906

SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE by Satelec - Acteon Group — Product Code EBZ

K131906 is an FDA 510(k) premarket notification submitted by Satelec - Acteon Group for the device "SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE". The FDA issued a decision of Substantially Equivalent on April 11, 2014. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Satelec - Acteon Group has at least 10 other 510(k) clearances on record.