510(k) Report

Devices descending from K130130

17 later devices reach Atg/SM-Osa Appliances through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243752Double Tube Herbst ApplianceThe Tmj Clinic PC20250—
+1K192581The NightBlocks ApplianceAdvanced Facialdontics, LLC20206—
+1K170578True Function Adjustable Herbst AppliancesTrue Function Laboratory, Inc.20170—
+1K162816SML-OSA2 AppliancesSelane Products, Inc.20170—
+1K130067Mrna ApplianceBiomodeling Solutions, Lls20145—
+1K130797Luco Hybrid Osa ApplianceLuco Hybrid Osa Appliance, Inc.20130—
+2K222872DNA ApplianceVivos Therapeutics, Inc.20222—
+2K210203mmRNA applianceVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)20210—
+2K191320Slow Wave DS8Slow Wave, Inc.20205—
+2K181123ApnoDent ApplianceApnomed, Inc.20180—
+3K233754AIO BreatheAiomega, LLC20241—
+3K230947C.A.R.E. Appliance (DNA, mRNA, mmRNA)Vivos Therapeutics, Inc.20231—
+3K230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC20231—
+3K220330Soundly Anti Snoring DeviceGreystone Ip, Ltd.20220—
+4K254304iNOS intraoral biosensorAchaemenid, LLC20260—
+4K252525AIO BreatheAiomega, LLC20250—
+4K234089DNA ApplianceVivos Therapeutics20240—