PRIME-DENT HEMA DESENSITIZER

PRIME-DENT HEMA DESENSITIZER is an FDA 510(k)-cleared medical device (K013970) manufactured by Prime Dental Manufacturing, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 18, 2002. Regulation: 8.