510(k) Report

Devices descending from K881422

6 later devices reach Coe Pak Auto Mix, Regular or Hard Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241283Elemental GranulateZinkh NV20250—
+1K083516PeriogenixOroscience, Inc.20091—
+1K050658Reso-Pac Periodontal DressingHager Worldwide, Inc.20054—
+2K251908Emanate TrayEmanate Biomedical20260—
+2K071484Periacryl 90,80,70,60, MODEL9010, 8020, 7030, 6040Glustitch, Inc.20071—
+3K142130Oral BondSteiner Laboratories20160—