Healix Assistant
Ask me anything about our products
Quick questions
Powered by Healix AI · Talk to a human

Sirona Dental Systems GmbH
Free shipping on orders over $99 · 30-day returns
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER is an FDA 510(k)-cleared medical device (K033675) manufactured by Sirona Dental Systems GmbH. 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 14, 2004. Regulation: 8.