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Northeast Resins & Silicones, LLC
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SILICONE IMPRESSION MATERIAL is an FDA 510(k)-cleared medical device (K011450) manufactured by Northeast Resins & Silicones, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 12, 2001. Regulation: 8.