
H.A. Opotow Consulting
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ESPE KETAC-ENDO APLICAP is an FDA 510(k)-cleared medical device (K911061) manufactured by H.A. Opotow Consulting. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 2, 1992. Regulation: 8.