510(k) Report

Devices descending from K083209

38 later devices reach Acrylic Herbst Splint Appliance through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183270Silent Nite slPrismatik Dentalcraft, Inc.201941
+1K172760REST EAZY ApplianceInsert Molding Solutions, Inc.20180—
+1K113126Acrylic Herbst ApplianceGergens Orthodontic Lab20132—
+1K123410Healthy Sleep ApplianceHealthy Sleep Dental Laboratory20130—
+1K111009Acrylic Herbst ApplianceEmbassy Dental Laboratory20113—
+1K101155Auradorm (Neuromuscular Sleep)Sleepwright20110—
+1K103076DynaflexDyna Flex201129—
+2K211069EndSnorZ Sleep AppliancePrismatik Dentalcraft, Inc.20211—
+2K210694Silent Nite Sleep Appliance with the Glidewell HingePrismatik Dentalcraft, Inc.20211—
+2K170578True Function Adjustable Herbst AppliancesTrue Function Laboratory, Inc.20170—
+2K160234OVENTOventus Manufacturing Pty, Ltd.20168—
+2K143591Dorsal ApplianceGergens Orthodontic Lab20150—
+2K130067Mrna ApplianceBiomodeling Solutions, Lls20145—
+2K130130Atg/SM-Osa AppliancesSelane Products, Inc.201317—
+3K243752Double Tube Herbst ApplianceThe Tmj Clinic PC20250—
+3K240427airVata™Gelb Practice Solutions, Inc.20240—
+3K233434Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)Prismatik Dentalcraft, Inc.20230—
+3K222872DNA ApplianceVivos Therapeutics, Inc.20222—
+3K210203mmRNA applianceVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)20210—
+3K192581The NightBlocks ApplianceAdvanced Facialdontics, LLC20206—
+3K181123ApnoDent ApplianceApnomed, Inc.20180—
+3K162816SML-OSA2 AppliancesSelane Products, Inc.20170—
+3K171316O2Vent WOventus Manufacturing Pty, Ltd.20176—
+3K161832O2VENT TOventus Manufacturing Pty, Ltd.20167—
+3K130797Luco Hybrid Osa ApplianceLuco Hybrid Osa Appliance, Inc.20130—
+4K230947C.A.R.E. Appliance (DNA, mRNA, mmRNA)Vivos Therapeutics, Inc.20231—
+4K191320Slow Wave DS8Slow Wave, Inc.20205—
+4K190236O2Vent OptimaOventus Manufacturing Pty, Ltd.20195—
+5K234089DNA ApplianceVivos Therapeutics20240—
+5K233754AIO BreatheAiomega, LLC20241—
+5K230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC20231—
+5K220330Soundly Anti Snoring DeviceGreystone Ip, Ltd.20220—
+5K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular…Meris Investment Group20213—
+6K254304iNOS intraoral biosensorAchaemenid, LLC20260—
+6K252942ShaeferHShaeferh, LLC20260—
+6K252525AIO BreatheAiomega, LLC20250—
+6K232735EMA 3DEma Sleep Incorporated20241—
+7K252698NightGuard Aire MaxNightguard Express, LLC20250—