Who else makes this device?

Name: MouthGuard
Brand: MouthGuard

MouthGuard

Reusable mouthguard intended to be placed between a patient’s teeth during medical procedures to protect teeth and oral structures. Constructed from rubber material and designed for…

Registry build 21.09.26

Reusable mouthguard intended to be placed between a patient’s teeth during medical procedures to protect teeth and oral structures. Constructed from rubber material and designed for repeated use with appropriate cleaning between uses.

4manufacturers in China registered for this device type

2catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JXL
Manufacturer	City	Province	Registered as	Device types
Sunmed AP, Ltd.	Zhuhai	Guangdong	Contract manufacturer	18
Sunmed AP, Ltd., Warehouse NO. 2	Zhuhai	Guangdong	Contract manufacturer	16
Yangdong Honghai Plastics Production Company	Yangjiang	Guangdong	Contract manufacturer	3
Yangjiang Junchang Trading Co., Ltd.	Yangjiang	Guangdong	Exporter	3

Record

Regulatory record for MouthGuard
Listed by	Somatics, LLC, United States
FDA product code	JXL
Device type	Block, Bite
Device class	Class 2
Regulation	21 CFR 882.5070
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K864181
Record published	2026-05-28

Specifications

Specifications
MRI safety	MR Safe
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for MouthGuard
Catalogue number	Size	Status
EMGS		In distribution
EMGD		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Hudson RCI	Teleflex Medical LLC	3
Cotton Bite Block	Sigmastim Domestic LLC	2
Ventil-A Oral Protector	Somatics, LLC	1
Pati	Neurovice, L.L.C.	1
Grafco	GF Health Products, Inc	1
Ethox Medical	Ethox Corp.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K992269	1999-10-25
K864181	1986-11-03

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.