Product Code: MQC FDA unclassified

Mouthguard, Prescription

Unknown

The Prescription Mouthguard is a dental device custom-fabricated under a dentist's prescription for use in protecting teeth and oral structures, commonly used to manage bruxism (teeth grinding), temporomandibular disorders, or during contact sports. This device is currently unclassified by the FDA, meaning its formal regulatory classification is pending. The product code is MQC, reviewed by the Dental panel.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MQC
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 71 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253798	UltraPrint-Dental Hard Splint UV	Mar 02, 2026	Substantially Equivalent	Guangzhou Heygears IMC., Inc.
K250743	Remvia NightGuard	Dec 05, 2025	Substantially Equivalent	Remvia
K251252	NOBILCAM IMPAK Disc	Aug 01, 2025	Substantially Equivalent	Shandong Huge Dental Material Corporation
K241729	Hard Splint & Thermo-Adaptive Splint	Mar 18, 2025	Substantially Equivalent	Whip Mix Corporation
K243516	Remi Custom Night Guard	Feb 10, 2025	Substantially Equivalent	Grindguard, Inc.
K241369	LIJIA Night Guard	Aug 22, 2024	Substantially Equivalent	Lijia, LLC
K231775	GR Resin System MSI	Aug 08, 2024	Substantially Equivalent	Pro3Dure Medical
K241311	Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)	Aug 02, 2024	Substantially Equivalent	Bernhard Förster GmbH
K240463	Slow Wave DS8 (SWDS802)	Jun 04, 2024	Substantially Equivalent	Slow Wave, Inc.
K231793	RODIN 3D Resin SPLINT, Hard/Flex	Mar 26, 2024	Substantially Equivalent	Belport Company, Inc., Gingi-Pak
K232087	Dental LT Comfort Resin	Feb 16, 2024	Substantially Equivalent	Formlabs Ohio, Inc.
K230548	Myoaligner Appliance	Feb 02, 2024	Substantially Equivalent	Myohealth Technologies, LLC
K230592	LuxCreo Dental Night Guard Resin	Jan 18, 2024	Substantially Equivalent	LuxCreo, Inc.
K222845	Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece	Nov 28, 2023	Substantially Equivalent	Frey Oral Technologies, LLC
K230495	Serena Sleep Night Guard	Oct 13, 2023	Substantially Equivalent	Meris Investment Group
K232448	FREEPRINT® splintmaster	Oct 12, 2023	Substantially Equivalent	Detax GmbH
K230237	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)	Sep 14, 2023	Substantially Equivalent	Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.
K222604	dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S	Apr 21, 2023	Substantially Equivalent	Dentona AG
K223798	Glidewell TuffSplint Appliance Resin	Feb 17, 2023	Substantially Equivalent	Prismatik Dentalcraft, Inc.
K222061	Dental LT Clear V2 Resin	Nov 10, 2022	Substantially Equivalent	Formlabs Ohio, Inc.
K221022	NextDent Ortho Flex	Oct 21, 2022	Substantially Equivalent	Vertex-Dental B.V.
K220894	SmileGuard	Jun 10, 2022	Substantially Equivalent	Envisiontec GmbH
K212017	Thermeo System	Apr 08, 2022	Substantially Equivalent	Pro3Dure Medical GmbH
K214102	Glidewell Appliance Resin, Hard/Soft	Feb 23, 2022	Substantially Equivalent	Prismatik Dentalcraft, Inc.
K212767	SleepRight Select-Comfort Dental Guard	Dec 22, 2021	Substantially Equivalent	Splintek, Inc.
K212448	NightGuard Flex	Nov 12, 2021	Substantially Equivalent	Sprintray, Inc.
K211415	GR Splint Resin System	Oct 21, 2021	Substantially Equivalent	Pro3Dure Medical GmbH
K210940	LuxaPrint Ortho Plus	Sep 03, 2021	Substantially Equivalent	Dmg Digital Enterprises SE
K210011	JS Dental Lab Mouth Guard	Jul 16, 2021	Substantially Equivalent	Ampower Dental Laboratories, LLC
K203596	Panthera Occlusal Appliance	Apr 20, 2021	Substantially Equivalent	Panthera Dental, Inc.
K203000	KeyPrint KeySplint Hard	Apr 09, 2021	Substantially Equivalent	Mycone Dental Supply Co. Inc. (Dba Keystone Industries)
K201173	E-Guard	Nov 27, 2020	Substantially Equivalent	Envisiontec GmbH
K202465	Night Guard	Nov 25, 2020	Substantially Equivalent	3D Diagnostix, Inc.
K201091	V-Print splint	Nov 06, 2020	Substantially Equivalent	Voco GmbH
K200125	Thermoforming Sheet Materials	Oct 28, 2020	Substantially Equivalent	Erkodent Erich Kopp GmbH
K191836	Ceramill A-Splint	Dec 20, 2019	Substantially Equivalent	Amann Girrbach AG
K183598	KeyPrint KeySplint Soft	Nov 15, 2019	Substantially Equivalent	Keystone Industries
K182820	The POD	Jul 17, 2019	Substantially Equivalent	Advanced Facialdontics, LLC
K190107	VeriSplint	Jul 10, 2019	Substantially Equivalent	Whip Mix Corporation
K181361	Brux Night Guard	Apr 11, 2019	Substantially Equivalent	Brux Night Guard
K170985	Urbanek Device	Sep 25, 2017	Substantially Equivalent	Tmj Services, LLC
K161884	Ortho System	Apr 19, 2017	Substantially Equivalent	3Shape A/S
K151933	BRX PRO Bruxism Guard	Dec 10, 2015	Substantially Equivalent	12th Man Technologies, Inc.
K143655	SICAT OPTIMOTION	Oct 02, 2015	Substantially Equivalent	Sicat GmbH & Co. KG
K143623	Narval Brux	Aug 13, 2015	Substantially Equivalent	Resmed Sas
K134015	M-PM-DISC	Apr 11, 2014	Substantially Equivalent	Merz Dental GmbH
K123161	SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE	Mar 14, 2013	Substantially Equivalent	Smartguard, Inc.
K121365	THERMOFORMED MOUTHGUARDS	Nov 20, 2012	Substantially Equivalent	Glidewell Laboratories-Sleep Devices Group
K112868	DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX	Jan 19, 2012	Substantially Equivalent	Dreamgard, Inc.
K102909	SOMNOBRUX SPLINTS	Dec 13, 2011	Substantially Equivalent	Somnomed, Inc.
K111066	MIGRA TAB, QUICKSPLINT MIGRAINE	Nov 22, 2011	Substantially Equivalent	Migratherapy, LLC
K111828	CLEARSPLINT ES	Oct 26, 2011	Substantially Equivalent	Astron Dental Corporation
K110468	FREEWAY COMFORT BITE GUARD	Aug 05, 2011	Substantially Equivalent	Randmark Dental Products, LLC
K091880	CLAYTON INTRA-AURAL DEVICE (CID)	Feb 24, 2010	Substantially Equivalent	Ascentia Health Incorporated
K090472	GRIND GUARD	Oct 14, 2009	Substantially Equivalent	Archtek, Inc.
K082723	GRINDGUARD	Aug 31, 2009	Substantially Equivalent	Grind Guard Technologies, LLC
K072522	THERMOFORM SHEET MATERIALS AND ACCESSORIES	Nov 16, 2007	Substantially Equivalent	Dentsply International, Inc.
K071404	SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE	Aug 17, 2007	Substantially Equivalent	Power Products, Inc.-Splintek
K061122	NIGHT GUARD	Mar 12, 2007	Substantially Equivalent	Alpine Oral Care, LLC
K063483	DEN TEK NIGHTGUARD	Jan 23, 2007	Substantially Equivalent	Den Tek Oral Care, Inc.
K062828	MOUTHGUARD AND ALIGNER MATERIALS	Nov 27, 2006	Substantially Equivalent	Dentsply Intl., Inc.
K053580	DOCTOR'S NIGHTGUARD	Mar 03, 2006	Substantially Equivalent	Dental Concepts, LLC
K040315	MYOHEALTH CLENCHING INHIBITOR	Aug 27, 2004	Substantially Equivalent	Mci-Myohealth Systems
K022809	EZ SPLINT & EZ SPLINT PM	Oct 17, 2003	Substantially Equivalent	Power Products, Inc.-Splintek
K030832	PRIMOSPLINT SYSTEM	Sep 17, 2003	Substantially Equivalent	Cosmedent, Inc.
K024261	DENTAL PROTECTOR	Mar 26, 2003	Substantially Equivalent	Dental Concepts, LLC
K022627	DSG RELAXER SPLINT	Mar 18, 2003	Substantially Equivalent	Sentage Corporation D/B/A/ Dental Services Group
K014079	DR. HAYS BITE GUARD	Feb 22, 2002	Substantially Equivalent	Inventive Resources, Inc.
K980953	ACCU-BITE HOME KIT DISCLUDER	Oct 07, 1998	Substantially Equivalent	Jerome M. Simon
K981546	NTI CLENCHING SUPPRESSION SYSTEM	Jul 15, 1998	Substantially Equivalent	Heraeus Kulzer, Inc.
K955701	NIGHTGUARD DIAGNOSTIC APPLIANCE	Mar 08, 1996	Substantially Equivalent	Cycura Corp.