
Howmedica Corp.
Free shipping on orders over $99 · 30-day returns
LUXENE VINYL-JECT 3600-80 is an FDA 510(k)-cleared medical device (K834046) manufactured by Howmedica 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 February 2, 1984. Regulation: 8.