
Xintec Corporation
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DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES is an FDA 510(k)-cleared medical device (K971065) manufactured by Xintec Corporation. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 16, 1997. Regulation: 8.