510(k) Report

Devices descending from K071404

52 later devices reach Sleep Right - Select, Low Profile and Advance through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212767SleepRight Select-Comfort Dental GuardSplintek, Inc.20210—
+1K172223SleepRight ProRx Custom Dental GuardSplintek, Inc.20173—
+1K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Smartguard, Inc.20139—
+1K123849New Comfort-Fit Dental GuardDen Tek Oral Care, Inc.20130—
+1K112879Rest Assured Ready to Wear Nite ProtectorRanir, LLC20122—
+1K110468Freeway Comfort Bite GuardRandmark Dental Products, LLC201110—
+1K100545SleeprightPower Products, Inc.-Splintek201030—
+1K090472Grind GuardArchtek, Inc.20090—
+1K072968Stressgard NightguardTotalgard Corporation20080—
+2K230548Myoaligner ApplianceMyohealth Technologies, LLC20240—
+2K212706SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental GuardSplintek, Inc.20210—
+2K193577SleepRight ProRx Custom Dental GuardSplintek, Inc.20202—
+2K151933BRX PRO Bruxism Guard12th Man Technologies, Inc.20150—
+2K133037GrindguardGrind Guard Technologies, LLC20146—
+2K133423Rest Assured Extra Comfort Nite ProtectorRanir, LLC20131—
+2K103004Snore GuardRanir, LLC201128—
+3K250743Remvia NightGuardRemvia20250—
+3K232238Goyo Mouthpiece SDimedikorea20240—
+3K181099Bright GuardKoncept Innovators, LLC20195—
+3K112205Snorerx 9.0Consumer Health Products, Inc.201126—
+3K101155Auradorm (Neuromuscular Sleep)Sleepwright20110—
+4K240810Anti Grinding GuardXiamen Yizhou Imp. & Exp. Co., Ltd.20240—
+4K221369FBCC Night GuardFbcc, Inc.20223—
+4K153200SnoreRxApnea Sciences Corporation201622—
+4K113569ApnearxApnea Science Corporation20124—
+5K252004enCore Night GuardEncore Guards20250—
+5K251778Remi Custom Night GuardRemi20251—
+5K223901ApneaRX ProApnea Sciences Coporation20231—
+5K181396Oral Device OA, Oral Device SPassion For Life Healthcare (Uk) Limited20180—
+5K170825SnoreRxApnea Sciences Corporation201721—
+5K162192BlueProBluesom20160—
+6K253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte., Ltd.20261—
+6K253641Owl Night GuardOwl Dental Lab, Inc.20260—
+6K252161Hushd AveraGood Sleep CO Pte, Ltd.20250—
+6K251628Mandibular Advancement Device L07Dcstar, Inc.20250—
+6K250122SleepRight Snore AidSplintek, Inc.20250—
+6K233850Difiney Anti Snoring DeviceFissiontech, LLC20243—
+6K200657SmartGuard Anti-Snoring DeviceSmartguard Rx, Inc.20212—
+6K203462Advanced Dental ApplianceDasoft Partners20210—
+6K201484Somnos Anti-Snoring Mouth GuardKoncept Innovators, LLC20201—
+6K191618SleepTight Mouthpiece STZMichael D Williams Dds PA20193—
+6K181482myTAP2Airway Management, Inc.20180—
+7K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.20260—
+7K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLC20260—
+7K261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.20260—
+7K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co.20261—
+7K250353Oniris; Oniris PlusOniris20250—
+7K250482Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 BlueFissiontech, LLC20251—
+7K231138Aniti-Snore Mouthguard+Oscimed SA20240—
+7K210910Snore BanditSnorebandit, LLC20210—
+8K261912SnØreNegatØrDnB Innovations, LLC20260—
+8K253355Difiney Advanced Anti Snoring Device 4.0Fissiontech, LLC20250—