
Oy Ajat, Ltd.
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SCAN300FP / RETROPAN (VDC) is an FDA 510(k)-cleared medical device (K051664) manufactured by Oy Ajat, Ltd.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 19, 2005. Regulation: 8.