
Ormco Corp.
Free shipping on orders over $99 · 30-day returns
HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL is an FDA 510(k)-cleared medical device (K902645) manufactured by Ormco Corp.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 5, 1990. Regulation: 8.