
New England Ortho Lab, Inc.
Free shipping on orders over $99 · 30-day returns
NEOLab Clear Aligners is an FDA 510(k)-cleared medical device (K203339) manufactured by New England Ortho Lab, Inc.. 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 5, 2021. Regulation: 8.