FDA.reportPublic FDA data

SomnoDent Brux

Primary DI
00851826007151
Brand
SomnoDent Brux
Company
SOMNOMED, INC.
Model
B1000-1012
Device description
Oral Device To Prevent Damage Due To Bruxism.
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102909000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102909000SOMNOBRUX SPLINTSSomnomed, Inc.2011-12-13MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851826007151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851826007151008518260071518518260071510851826007151

GMDN Terms#

Term, Definition table
TermDefinition
Mandible-repositioning sleep-disordered breathing orthosisA removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8884476673customerservice@somnomed.com

Regulatory Flags#

DUNS number
623527962
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851826007281SomnoDent AVANTSomnoDent AVANT with Strap Kit A2024-08-14
00851826007298SomnoDent AVANTSomnoDent AVANT with Strap Kit B2024-08-14
00851826007304SomnoDent AVANTSomnoDent AVANT with Strap Kit C2024-08-14
00851826007311SomnoDent AVANTAVANT Strap Kit A2024-08-14
00851826007328SomnoDent AVANTAVANT Strap Kit B2024-08-14
00851826007335SomnoDent AVANTAVANT Strap Kit C2024-08-14
00851826007342SomnoDent AVANTAVANT Strap Kit D2024-08-14
00851826007199SomnoDent AVANT AVANT-L2019-08-29
00851826007205SomnoDent AVANT AVANT-M2019-08-29
00851826007212SomnoDent AVANT AVANT-S2019-08-29
00851826007229SomnoDent AVANT AVANT-Strap SMALL2019-08-29
00851826007236SomnoDent AVANTAVANT-Strap MEDIUM2019-08-29
00851826007243SomnoDent AVANTAVANT Strap LARGE2019-08-29
00851826007007SomnoDent AirAir1002016-10-14
00851826007014SomnoDent Air+Air1402016-10-14
00851826007021ClassicC10002016-10-14
00851826007038FlexF30002016-10-14
00851826007045Fusion FlexL70012016-10-14
00851826007052Fusion ClassicL70002016-10-14
00851826007069Herbst Advance FlexH30402016-10-14

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