SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE

SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE is an FDA 510(k)-cleared medical device (K131906) manufactured by Satelec - Acteon Group. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 10, 2014. Regulation: 8.