FDA.reportPublic FDA data

VENTIL-A Oral Protector

Primary DI
00850298007034
Brand
VENTIL-A Oral Protector
Company
SOMATICS, LLC
Model
VENT
Catalog number
VENT
Device description
Single-use mouth protector intended for use during electroconvulsive therapy (ECT) to protect teeth and oral structures. Constructed from closed-cell foam and designed with an internal airway channel to allow airflow during use with anesthesia masks. Disposable design eliminates the need for cleaning and reduces the risk of cross-contamination.
Published
2026-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JXLBlock, Bite

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXLBlock, BiteNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992269000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992269000VENTIL-A ORAL PROTECTORSomatics, Inc.1999-10-25JXL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850298007034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850298007034008502980070348502980070340850298007034

GMDN Terms#

Term, Definition table
TermDefinition
Mouthguard, single-useA prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during surgery or intubation. It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth. This is a single-use device.

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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850298007058MouthGuardEMGSEMGS2026-05-28
00850298007072Monitoring Lead Wires, Set of 9ELDSC-92026-05-28
00850298007041MouthGuardEMGDEMGD2026-05-27
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
00850298007041MouthGuardSOMATICS, 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