Atlas FDA

MQC

71 FDA 510(k) clearances · Product code

184 daysmedian time to decision
323 days90th percentile
71clearances measured

FDA profile

Official device name
Mouthguard, Prescription
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
2019: 62 · 2020: 46 · 2021: 111 · 2022: 137 · 2023: 62 · 2026: 23
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
UltraPrint-Dental Hard Splint UV (K253798)Guangzhou Heygears IMC., Inc.2026-03-02
Remvia NightGuard (K250743)Remvia2025-12-05
NOBILCAM IMPAK Disc (K251252)Shandong Huge Dental Material Corporation2025-08-01
Hard Splint & Thermo-Adaptive Splint (K241729)Whip Mix Corporation2025-03-18
Remi Custom Night Guard (K243516)Grindguard, Inc.2025-02-10
LIJIA Night Guard (K241369)Lijia, LLC2024-08-22
GR Resin System MSI (K231775)Pro3Dure Medical2024-08-08
Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) (K241311)Bernhard Förster GmbH2024-08-02
Slow Wave DS8 (SWDS802) (K240463)Slow Wave, Inc.2024-06-04
RODIN 3D Resin SPLINT, Hard/Flex (K231793)Belport Company, Inc., Gingi-Pak2024-03-26
Dental LT Comfort Resin (K232087)Formlabs Ohio, Inc.2024-02-16
Myoaligner Appliance (K230548)Myohealth Technologies, LLC2024-02-02
LuxCreo Dental Night Guard Resin (K230592)LuxCreo, Inc.2024-01-18
Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece (K222845)Frey Oral Technologies, LLC2023-11-28
Serena Sleep Night Guard (K230495)Meris Investment Group2023-10-13
FREEPRINT® splintmaster (K232448)Detax GmbH2023-10-12
Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0) (K230237)Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.2023-09-14
dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S (K222604)Dentona AG2023-04-21
Glidewell TuffSplint™ Appliance Resin (K223798)Prismatik Dentalcraft, Inc.2023-02-17
Dental LT Clear V2 Resin (K222061)Formlabs Ohio, Inc.2022-11-10
NextDent Ortho Flex (K221022)Vertex-Dental B.V.2022-10-21
SmileGuard (K220894)Envisiontec GmbH2022-06-10
Thermeo System (K212017)Pro3Dure Medical GmbH2022-04-08
Glidewell Appliance Resin, Hard/Soft (K214102)Prismatik Dentalcraft, Inc.2022-02-23
SleepRight Select-Comfort Dental Guard (K212767)Splintek, Inc.2021-12-22
NightGuard Flex (K212448)Sprintray, Inc.2021-11-12
GR Splint Resin System (K211415)Pro3Dure Medical GmbH2021-10-21
LuxaPrint Ortho Plus (K210940)Dmg Digital Enterprises SE2021-09-03
JS Dental Lab Mouth Guard (K210011)Ampower Dental Laboratories, LLC2021-07-16
Panthera Occlusal Appliance (K203596)Panthera Dental, Inc.2021-04-20
KeyPrint KeySplint Hard (K203000)Mycone Dental Supply Co. Inc. (Dba Keystone Industries)2021-04-09
E-Guard (K201173)Envisiontec GmbH2020-11-27
Night Guard (K202465)3D Diagnostix, Inc.2020-11-25
V-Print splint (K201091)Voco GmbH2020-11-06
Thermoforming Sheet Materials (K200125)Erkodent Erich Kopp GmbH2020-10-28
Ceramill A-Splint (K191836)Amann Girrbach AG2019-12-20
KeyPrint KeySplint Soft (K183598)Keystone Industries2019-11-15
The POD (K182820)Advanced Facialdontics, LLC2019-07-17
VeriSplint (K190107)Whip Mix Corporation2019-07-10
Brux Night Guard (K181361)Brux Night Guard2019-04-11
Urbanek Device (K170985)Tmj Services, LLC2017-09-25
Ortho System (K161884)3Shape A/S2017-04-19
BRX PRO Bruxism Guard (K151933)12th Man Technologies, Inc.2015-12-10
SICAT OPTIMOTION (K143655)Sicat GmbH & Co. KG2015-10-02
Narval Brux (K143623)Resmed Sas2015-08-13
M-PM-DISC (K134015)Merz Dental GmbH2014-04-11
SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE (K123161)Smartguard, Inc.2013-03-14
THERMOFORMED MOUTHGUARDS (K121365)Glidewell Laboratories-Sleep Devices Group2012-11-20
DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX (K112868)Dreamgard, Inc.2012-01-19
SOMNOBRUX SPLINTS (K102909)Somnomed, Inc.2011-12-13
MIGRA TAB, QUICKSPLINT MIGRAINE (K111066)Migratherapy, LLC2011-11-22
CLEARSPLINT ES (K111828)Astron Dental Corporation2011-10-26
FREEWAY COMFORT BITE GUARD (K110468)Randmark Dental Products, LLC2011-08-05
CLAYTON INTRA-AURAL DEVICE (CID) (K091880)Ascentia Health Incorporated2010-02-24
GRIND GUARD (K090472)Archtek, Inc.2009-10-14
GRINDGUARD (K082723)Grind Guard Technologies, LLC2009-08-31
THERMOFORM SHEET MATERIALS AND ACCESSORIES (K072522)Dentsply International, Inc.2007-11-16
SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE (K071404)Power Products, Inc.-Splintek2007-08-17
NIGHT GUARD (K061122)Alpine Oral Care, LLC2007-03-12
DEN TEK NIGHTGUARD (K063483)Den Tek Oral Care, Inc.2007-01-23
MOUTHGUARD AND ALIGNER MATERIALS (K062828)Dentsply Intl., Inc.2006-11-27
DOCTOR'S NIGHTGUARD (K053580)Dental Concepts, LLC2006-03-03
MYOHEALTH CLENCHING INHIBITOR (K040315)Mci-Myohealth Systems2004-08-27
EZ SPLINT & EZ SPLINT PM (K022809)Power Products, Inc.-Splintek2003-10-17
PRIMOSPLINT SYSTEM (K030832)Cosmedent, Inc.2003-09-17
DENTAL PROTECTOR (K024261)Dental Concepts, LLC2003-03-26
DSG RELAXER SPLINT (K022627)Sentage Corporation D/B/A/ Dental Services Group2003-03-18
DR. HAYS BITE GUARD (K014079)Inventive Resources, Inc.2002-02-22
ACCU-BITE HOME KIT DISCLUDER (K980953)Jerome M. Simon1998-10-07
NTI CLENCHING SUPPRESSION SYSTEM (K981546)Heraeus Kulzer, Inc.1998-07-15
NIGHTGUARD DIAGNOSTIC APPLIANCE (K955701)Cycura Corp.1996-03-08

Track MQC automatically

Every clearance here is in the API, with alerts when new ones post.