
Paragon Implant Mfg., LLC
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GEN5 and GEN5+ 3.3mmD Dental Implants is an FDA 510(k)-cleared medical device (K252145) manufactured by Paragon Implant Mfg., 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 December 22, 2025. Regulation: 8.