
Austenal Dental, Inc.
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BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN is an FDA 510(k)-cleared medical device (K883799) manufactured by Austenal Dental, 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 October 19, 1988. Regulation: 8.