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Sybron Dental Specialties, Inc.
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POINT 4 MODIFIED is an FDA 510(k)-cleared medical device (K013510) manufactured by Sybron Dental Specialties, 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 January 17, 2002. Regulation: 8.