HDS INTRA-ORAL IMAGING SYSTEM

HDS INTRA-ORAL IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K042372) manufactured by Vatech Value Added Technology Co., 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 October 3, 2004. Regulation: 8.