
Demetron Research Corp.
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OPTILUX & VISILUX DENTAL PHOTO LAMP is an FDA 510(k)-cleared medical device (K822642) manufactured by Demetron Research Corp.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 1982. Regulation: 8.