
Ohlendorf Appliance Laboratory
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Ohlendorf Clear Aligner is an FDA 510(k)-cleared medical device (K210540) manufactured by Ohlendorf Appliance Laboratory. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 18, 2021. Regulation: 8.