OBR · Mouthguard, Over-The-Counter · Chrysalis Intelligence

Device class

Unclassified

Regulation —

Total clearances

2020-01-15 → 2026-09-16

Last 12 months

Unique sponsors

Definition

What is Mouthguard, Over-The-Counter

To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.

Classification details

Medical specialty

Unknown

Review panel

Regulation number

—

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Players

Sponsor	Clearances	Last 12 mo	Most recent
Boyd Research, Inc.	2	0	2021-09-17
Doc Brands, Inc.	2	0	2025-05-19
Splintek, Inc.	2	0	2021-12-13
1987 Media Limited	1	1	2026-04-10
Medtech Products, Inc.	1	0	2020-12-22
Encore Guards	1	1	2025-11-25
Xiamen Yizhou Imp. & Exp. Co., Ltd.	1	0	2024-05-24
Dimedikorea	1	0	2024-04-17
Remi	1	1	2025-10-17
Fbcc, Inc.	1	0	2022-11-18
ASESSO HEALTH, Inc.	1	1	2026-06-25
Reazeal Corp	1	0	2023-11-06
Owl Dental Lab, Inc.	1	1	2026-02-26
ChangSha ChuangDuoLe E-Commerce Co., Ltd.	1	1	2026-09-16

Pulse

Date	K-number	Sponsor	Device
2026-09-16	K262559	ChangSha ChuangDuoLe E-Commerce Co., Ltd.	Mouth Guard
2026-06-25	K260790	ASESSO HEALTH, Inc.	G-Series Grind Guard
2026-04-10	K252485	1987 Media Limited	ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))
2026-02-26	K253641	Owl Dental Lab, Inc.	Owl Night Guard
2025-11-25	K252004	Encore Guards	enCore Night Guard
2025-10-17	K251778	Remi	Remi Custom Night Guard
2025-05-19	K250456	Doc Brands, Inc.	Dentemp Pro-Comfort Dental Guard
2024-05-24	K240810	Xiamen Yizhou Imp. & Exp. Co., Ltd.	Anti Grinding Guard
2024-04-17	K232238	Dimedikorea	Goyo Mouthpiece S
2023-11-06	K231865	Reazeal Corp	Mouth Guard (ATG0603R)
2022-11-18	K221369	Fbcc, Inc.	FBCC Night Guard
2022-10-07	K222424	Doc Brands, Inc.	Protect-It Custom Fit Dental Guard
2021-12-13	K212706	Splintek, Inc.	SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
2021-09-17	K211158	Boyd Research, Inc.	NTI ClenchGuard
2020-12-22	K202974	Medtech Products, Inc.	DenTek Fresh Protect Dental Guard
2020-06-01	K193577	Splintek, Inc.	SleepRight ProRx Custom Dental Guard
2020-01-15	K181005	Boyd Research, Inc.	ClenchGuard