
Coe Laboratories, Inc.
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ABSOLUTE VINYL POLYSILOXANE IMPRESS is an FDA 510(k)-cleared medical device (K842877) manufactured by Coe Laboratories, 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 March 10, 1985. Regulation: 8.