FDA.reportPublic FDA data

MouthGuard

Primary DI
00850298007041
Brand
MouthGuard
Company
SOMATICS, LLC
Model
EMGD
Catalog number
EMGD
Device 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.
Published
2026-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JXLBlock, Bite

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXLBlock, BiteNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864181000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864181000SOMATICS MOUTH GUARD (BITE BLOCK)Somatics, Inc.1986-11-03JXL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850298007041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850298007041008502980070418502980070410850298007041

GMDN Terms#

Term, Definition table
TermDefinition
Mouthguard, reusableA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
187194337
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850298007058MouthGuardEMGSEMGS2026-05-28
00850298007072Monitoring Lead Wires, Set of 9ELDSC-92026-05-28
00850298007034VENTIL-A Oral ProtectorVENTVENT2026-05-27
00850298007010ThymapadEPADEPAD2026-05-18
00850298007003Thymatron IVSystem IVEDIV2018-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850298007058MouthGuardSOMATICS, LLCJXL2026-05-28
00850298007034VENTIL-A Oral ProtectorSOMATICS, LLCJXL2026-05-27
00860015137906PATINEUROVICE, L.L.C.JXL2025-12-19
10850045508071Cotton Bite BlockSIGMASTIM DOMESTIC, LLCJXL2025-01-27
10850045508088Cotton Bite BlockSIGMASTIM DOMESTIC, LLCJXL2025-01-27
14026704646545HUDSON RCITELEFLEX INCORPORATEDJXL2019-04-24
24026704646542HUDSON RCITELEFLEX INCORPORATEDJXL2019-04-24
14026704580221HUDSON RCITELEFLEX INCORPORATEDJXL2018-09-15
04026704580224HUDSON RCITELEFLEX INCORPORATEDJXL2018-09-15
34026704580225HUDSON RCITELEFLEX INCORPORATEDJXL2018-09-15
10889483150030Ethox MedicalETHOX MEDICAL, LLCJXL2016-09-27
20889483150037Ethox MedicalETHOX MEDICAL, LLCJXL2016-09-27
M36837891GrafcoGF HEALTH PRODUCTS, INC.JXL2016-08-31