
Elevate Oral Care, LLC
Free shipping on orders over $99 · 30-day returns
Black Diamond is an FDA 510(k)-cleared medical device (K222323) manufactured by Elevate Oral Care, LLC. 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 22, 2023. Regulation: 8.