510(k) Report

Devices descending from K103076

29 later devices reach Dynaflex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170578True Function Adjustable Herbst AppliancesTrue Function Laboratory, Inc.20170—
+1K160234OVENTOventus Manufacturing Pty, Ltd.20168—
+1K130067Mrna ApplianceBiomodeling Solutions, Lls20145—
+1K130130Atg/SM-Osa AppliancesSelane Products, Inc.201317—
+1K113126Acrylic Herbst ApplianceGergens Orthodontic Lab20132—
+1K111009Acrylic Herbst ApplianceEmbassy Dental Laboratory20113—
+2K243752Double Tube Herbst ApplianceThe Tmj Clinic PC20250—
+2K222872DNA ApplianceVivos Therapeutics, Inc.20222—
+2K210203mmRNA applianceVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)20210—
+2K192581The NightBlocks ApplianceAdvanced Facialdontics, LLC20206—
+2K181123ApnoDent ApplianceApnomed, Inc.20180—
+2K162816SML-OSA2 AppliancesSelane Products, Inc.20170—
+2K171316O2Vent WOventus Manufacturing Pty, Ltd.20176—
+2K161832O2VENT TOventus Manufacturing Pty, Ltd.20167—
+2K143591Dorsal ApplianceGergens Orthodontic Lab20150—
+2K130797Luco Hybrid Osa ApplianceLuco Hybrid Osa Appliance, Inc.20130—
+3K230947C.A.R.E. Appliance (DNA, mRNA, mmRNA)Vivos Therapeutics, Inc.20231—
+3K191320Slow Wave DS8Slow Wave, Inc.20205—
+3K190236O2Vent OptimaOventus Manufacturing Pty, Ltd.20195—
+4K234089DNA ApplianceVivos Therapeutics20240—
+4K233754AIO BreatheAiomega, LLC20241—
+4K230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC20231—
+4K220330Soundly Anti Snoring DeviceGreystone Ip, Ltd.20220—
+4K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular…Meris Investment Group20213—
+5K254304iNOS intraoral biosensorAchaemenid, LLC20260—
+5K252942ShaeferHShaeferh, LLC20260—
+5K252525AIO BreatheAiomega, LLC20250—
+5K232735EMA 3DEma Sleep Incorporated20241—
+6K252698NightGuard Aire MaxNightguard Express, LLC20250—