PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS

PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS is an FDA 510(k)-cleared medical device (K970992) manufactured by Premier Dental Products Co.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 16, 1997. Regulation: 8.