MQC

Product Code: MQC

Products Classified as MQC

1408

Mouthguard, Prescription

Total Product Life Cycle (TPLC) Devices

1408

Mouthguard, Prescription

FDA Consensus Standards

• Mouthguard, Prescription [35851]: 21 CFR Unclassified 🔎
• Mouthguard, Prescription [38733]: 21 CFR Unclassified 🔎
• Mouthguard, Prescription [35869]: 21 CFR Unclassified 🔎

Pre-market Notifications for MQC

K222061	Dental LT Clear V2 Resin	Formlabs Ohio, Inc.
K221022	NextDent Ortho Flex	Vertex-Dental BV
K220894	SmileGuard	EnvisionTEC GmbH
K214102	Glidewell Appliance Resin, Hard/Soft	Prismatik Dentalcraft, Inc.
K212767	SleepRight Select-Comfort Dental Guard	Splintek, Inc.
K212448	NightGuard Flex	SprintRay Inc
K212017	Thermeo System	Pro3dure Medical GmbH
K211415	GR Splint Resin System	Pro3dure Medical GmbH
K210940	LuxaPrint Ortho Plus	DMG Digital Enterprises SE
K210011	JS Dental Lab Mouth Guard	Ampower Dental Laboratories, LLC
K203000	KeyPrint KeySplint Hard	Mycone Dental Supply Co. Inc. (DBA Keystone Industries)
K202465	Night Guard	3D Diagnostix Inc.
K201173	E-Guard	EnvisionTEC GmbH
K201091	V-Print Splint	VOCO GmbH
K200125	Thermoforming Sheet Materials	Erkodent Erich Kopp GmbH

Global Unique Device Identification Database

• 00859290006151: Mouthguard, Prescription
• 00851826007151: Mouthguard, Prescription
• D746IS25110801: Mouthguard, prescription
• D746IS25110201: Mouthguard, prescription
• D746WHWDGSC060BMS1: Mouthguard, prescription
• D746WHWDGSC040BMS1: Mouthguard, prescription
• D746UFS080X5R1: Mouthguard, prescription
• D746UFS080X50S1: Mouthguard, prescription
• D746UFS080X25R1: Mouthguard, prescription
• D746UFS060X5S1: Mouthguard, prescription
• D746UFS060X5R1: Mouthguard, prescription
• D746UFS060X50SS1: Mouthguard, prescription
• D746UFS060X50S1: Mouthguard, prescription
• D746UFS060X50R1: Mouthguard, prescription
• D746UFS060X25S1: Mouthguard, prescription

Maude Adverse Events

COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT, INC.	2020-03-23
COMFORT HARD-SOFT BITE SPLINT?	PRISMATIK DENTALCRAFT, INC.	2020-02-24
ASTRON CLEAR SPLINTS?	PRISMATIK DENTALCRAFT, INC.	2020-02-24
COMFORT HARD-SOFT BITE SPLINT?	PRISMATIK DENTALCRAFT, INC.	2020-02-24
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT, INC.	2020-02-20
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT, INC.	2020-02-19
SEMI-HARD NIGHTGUARD	PRISMATIK DENTALCRAFT, INC.	2020-02-10
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT, INC.	2020-02-06
ASTRON CLEAR SPLINT LOWER	PRISMATIK DENTALCRAFT, INC.	2020-01-30
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT, INC.	2020-01-20
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT, INC.	2020-01-20
MOUTHGUARD	PRISMATIK DENTALCRAFT, INC.	2020-01-17
COMFORT HARD-SOFT SPLINT	PRISMATIK DENTALCRAFT, INC.	2020-01-16
ASTRON CLEAR SPRINT	PRISMATIK DENTALCRAFT, INC.	2020-01-14
COMFORT HARD-SOFT SPLINT UPPER	PRISMATIK DENTALCRAFT, INC.	2020-01-14
ASTRON CLEAR SPLINTS	PRISMATIK DENTALCRAFT, INC.	2019-12-17
ASTRON CLEAR SPLINTS	PRISMATIK DENTALCRAFT, INC.	2019-12-17
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT INC.	2019-12-10
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT INC.	2019-12-10
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT INC.	2019-12-10
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT INC.	2019-11-25
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT INC.	2019-10-15
SOFT NIGHT GUARD	PRISMATIK DENTALCRAFT INC.	2019-10-12
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT INC.	2019-10-07
COMFORT SPLINT	PRISMATIK DENTALCRAFT INC.	2019-10-07
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT INC.	2019-10-02
ASTRON CLEAR SPLINTS	PRISMATIK DENTALCRAFT INC.	2019-09-17
ASTRON CLEAR SPLINTS	PRISMATIK DENTALCRAFT INC.	2019-09-16
COMFORT HARD-SOFT BITE SPLIN	PRISMATIK DENTALCRAFT INC.	2019-09-05
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT INC.	2019-08-29
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT INC.	2019-08-29
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT INC.	2019-08-29
ASTRON CLEAR SPLINT	PRISMATIK DENTALCRAFT INC.	2019-08-08
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT INC.	2019-08-08
ASTRON CLEARSPLINTS	PRISMATIK DENTALCRAFT, INC.	2019-08-01
ASTRON CLEARSPLINTS	PRISMATIK DENTALCRAFT, INC.	2019-07-31
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT, INC.	2019-07-31
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT, INC.	2019-07-15
COMFORT HARD BITE SPLINT	PRISMATIK DENTALCRAFT, INC.	2019-07-15
MOUTHGUARD	UNK	2019-06-18
COMFORT HARD BITE SPLINT	PRISMATIK DENTALCRAFT, INC.	2019-05-30
ASTRON CLEARSPLINTS	PRISMATIK DENTALCRAFT, INC.	2019-05-21
ASTRON CLEARSPLINTS	PRISMATIK DENTALCRAFT, INC.	2019-05-21
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT, INC.	2019-05-14
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT, INC.	2019-05-14
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT, INC.	2019-05-14
ASTRON CLEARSPLINTS	PRISMATIK DENTALCRAFT, INC.	2019-05-14
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT, INC.	2019-05-02
COMFORT HARD-SOFT BITE SPLINT	PRISMATIK DENTALCRAFT, INC.	2019-04-16
ASTRON CLEARSPLINTS	PRISMATIK DENTALCRAFT, INC.	2019-04-16