# MQC · Mouthguard, Prescription

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/DE-misc/MQC

## Overview

- **Product Code:** MQC
- **Device Name:** Mouthguard, Prescription
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (20 of 71)

Showing 20 most recent of 71 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253798](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K253798.md) | UltraPrint-Dental Hard Splint UV | Guangzhou Heygears IMC., Inc. | Mar 2, 2026 | SESE |
| [K250743](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K250743.md) | Remvia NightGuard | Remvia | Dec 5, 2025 | SESE |
| [K251252](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K251252.md) | NOBILCAM IMPAK Disc | Shandong Huge Dental Material Corporation | Aug 1, 2025 | SESE |
| [K241729](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K241729.md) | Hard Splint & Thermo-Adaptive Splint | Whip Mix Corporation | Mar 18, 2025 | SESE |
| [K243516](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K243516.md) | Remi Custom Night Guard | Grindguard, Inc. | Feb 10, 2025 | SESE |
| [K241369](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K241369.md) | LIJIA Night Guard | Lijia, LLC | Aug 22, 2024 | SESE |
| [K231775](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K231775.md) | GR Resin System MSI | Pro3Dure Medical | Aug 8, 2024 | SESE |
| [K241311](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K241311.md) | Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) | Bernhard Förster GmbH | Aug 2, 2024 | SESE |
| [K240463](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K240463.md) | Slow Wave DS8 (SWDS802) | Slow Wave, Inc. | Jun 4, 2024 | SESE |
| [K231793](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K231793.md) | RODIN 3D Resin SPLINT, Hard/Flex | Belport Company, Inc., Gingi-Pak | Mar 26, 2024 | SESE |
| [K232087](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K232087.md) | Dental LT Comfort Resin | Formlabs Ohio, Inc. | Feb 16, 2024 | SESE |
| [K230548](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K230548.md) | Myoaligner Appliance | Myohealth Technologies, LLC | Feb 2, 2024 | SESE |
| [K230592](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K230592.md) | LuxCreo Dental Night Guard Resin | LuxCreo, Inc. | Jan 18, 2024 | SESE |
| [K222845](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K222845.md) | Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece | Frey Oral Technologies, LLC | Nov 28, 2023 | SESE |
| [K230495](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K230495.md) | Serena Sleep Night Guard | Meris Investment Group | Oct 13, 2023 | SESE |
| [K232448](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K232448.md) | FREEPRINT® splintmaster | Detax GmbH | Oct 12, 2023 | SESE |
| [K230237](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K230237.md) | 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) | Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. | Sep 14, 2023 | SESE |
| [K222604](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K222604.md) | dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S | Dentona AG | Apr 21, 2023 | SESE |
| [K223798](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K223798.md) | Glidewell TuffSplint™ Appliance Resin | Prismatik Dentalcraft, Inc. | Feb 17, 2023 | SESE |
| [K222061](https://fda.innolitics.com/submissions/DE/DE-misc/MQC/K222061.md) | Dental LT Clear V2 Resin | Formlabs Ohio, Inc. | Nov 10, 2022 | SESE |

## Top Applicants

- Dental Concepts, LLC — 2 clearances
- Envisiontec GmbH — 2 clearances
- Formlabs Ohio, Inc. — 2 clearances
- Power Products, Inc.-Splintek — 2 clearances
- Prismatik Dentalcraft, Inc. — 2 clearances

---

**Source:** [https://fda.innolitics.com/submissions/DE/DE-misc/MQC](https://fda.innolitics.com/submissions/DE/DE-misc/MQC)

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