
Astra Tech AB
Free shipping on orders over $99 · 30-day returns
ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT is an FDA 510(k)-cleared medical device (K101005) manufactured by Astra Tech AB. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 20, 2011. Regulation: 8.