Device
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 fo...
Manufacturer
SOMATICS, LLC
SOMATICS, LLC
Model: EMGS
Catalog: EMGS
DI: 00850298007058
Status: New
MRI: MR Safe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-28
Current Version: 2026-06-05
Description
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.
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
739d143d-2c47-4c65-9860-ed6b21ffad19
Distribution Status:
In Commercial Distribution
DUNS Number:
187194337
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00850298007058
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10850298007048
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
1
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
00850298007058
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 38621
Name: Mouthguard, reusable
Definition:
A prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during endoscopic diagnostic procedures, contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth; some types are referred to as nightguards or bite raising appliances. This is a reusable device.
FDA Product Codes
JXL
Block, Bite
Premarket Submissions
Submission Number:
K864181
Supplement Number:
000