510(k) Report

Devices descending from K192221

3 later devices reach Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252145GEN5™ and GEN5+™ 3.3mmD Dental ImplantsParagon Implant Mfg., LLC20250—
+1K251938GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC20251—
+2K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—