
Planmeca USA, Inc.
Free shipping on orders over $99 · 30-day returns
PLANMECA SOVEREIGN is an FDA 510(k)-cleared medical device (K081699) manufactured by Planmeca USA, Inc.. This device is classified under the Dental specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 28, 2008. Regulation: 8.