510(k) Report

Devices descending from K043504

10 later devices reach Palaimpact through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111832Paladon Ultra Powder (Pink), Paladon Ultra LiquidHeraeus Kulzer, LLC20119—
+2K132725Juvora Dentqal DiscJuvora20148—
+3K160918JUVORA Dental Disc, Ceramill PEEK by JUVORAJuvora20173—
+3K152113BioHPP - breCAM.BioHPPBredent GmbH & Co. KG20163—
+4K233171PF Keep; Cad Cam Keep BlockClemde SA DE CV20230—
+4K220329G-CAMGraphenano Dental S.L.202211
+4K181484Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral TissueZirkonzahn Srl20180—
+4K173124PEEK BiosolutionMerz Dental GmbH20170—
+4K170102Pekkton IvoryCendres+Metaux SA20170—
+5K253236G-BlockGraphenano Dental S.L.20250—