
The Hygenic Corp.
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ENDO-ICE-PULP TESTER-THERMAL is an FDA 510(k)-cleared medical device (K930764) manufactured by The Hygenic Corp.. 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 26, 1993. Regulation: 8.