MQC

FDA Product Code MQC: Mouthguard, Prescription

Leading manufacturers include Prismatik Dentalcraft, Inc., Bernhard F?rster GmbH and Lijia, LLC.

Total

Cleared

190d

Avg days

1996

Since

Declining activity - 9 submissions in the last 2 years vs 13 in the prior period

Consistent review times: 171d avg (recent)

FDA 510(k) Cleared Mouthguard, Prescription Devices (Product Code MQC)

71 devices

1–24 of 71

Cleared Mar 02, 2026

UltraPrint-Dental Hard Splint UV

K253798

Guangzhou Heygears IMC., Inc.

Shandong Huge Dental Material Corporation

Dental · 100d

Cleared Mar 18, 2025

Hard Splint & Thermo-Adaptive Splint

Remi Custom Night Guard

Thermoforming Sheet Materials (Track A)

K241311

Bernhard F?rster GmbH

Dental · 85d

Cleared Jun 04, 2024

Slow Wave DS8 (SWDS802)

RODIN 3D Resin SPLINT, Hard/Flex

K231793

Belport Company, Inc., Gingi-Pak

Dental · 280d

Cleared Feb 16, 2024

Dental LT Comfort Resin

Myohealth Technologies, LLC

Dental · 339d

Cleared Jan 18, 2024

LuxCreo Dental Night Guard Resin

Glidewell TuffSplint™ Appliance Resin

K223798

Prismatik Dentalcraft, Inc.

Dental · 60d

Cleared Feb 23, 2022

Glidewell Appliance Resin, Hard/Soft

K214102

Prismatik Dentalcraft, Inc.

Dental · 56d

About Product Code MQC - Regulatory Context

510(k) Submission Activity

71 total 510(k) submissions under product code MQC since 1996, with 71 receiving FDA clearance (average review time: 190 days).

Submission volume has declined in recent years - 9 submissions in the last 24 months compared to 13 in the prior period.

FDA Review Time

FDA review times for MQC submissions have been consistent, averaging 171 days recently vs 193 days historically.

MQC devices are reviewed by the Dental panel. Browse all Dental devices →