FDA.reportPublic FDA data

SomnoDent AVANT

Primary DI
00851826007335
Brand
SomnoDent AVANT
Company
SOMNOMED, INC.
Model
AVANT Strap Kit C
Device description
SomnoDent AVANT Strap Kit C
Published
2024-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRKDevice, Anti-Snoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRKDevice, Anti-SnoringDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183443000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183443000SomnoDent AvantSomnomed, Inc.2019-05-08LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851826007335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851826007335008518260073358518260073350851826007335

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
888-447-6673customerservice@somnomed.com

Regulatory Flags#

DUNS number
623527962
Device count
1
Lot or batch
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
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
00851826007076Herbst Telescopic ClassicH10002016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D854413871967328267319ApnoDentSELANE PRODUCTS, INC.LRK2026-05-29
00860005753093Serena SureSERENA SLEEP SOLUTIONS LLCLRK2026-05-20
00851085006247Nylon flexTAP Oral ApplianceAIRWAY TECHNOLOGIES, LLCLRK2026-05-08
00851085006254Nylon flexTAP Oral Appliance KitAIRWAY TECHNOLOGIES, LLCLRK2026-05-08
D775IBASA0Herbst -Banded Upper Or Lower-Single ArchGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBN0Bonded HerbstGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBNE0Bonded Herbst - RPEGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBNER0Bonded Herbst - RPE Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBNR0Bonded Herbst-Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESLRK2026-04-24
00860015650405EMADENTAL PROSTHETIC SERVICES, INC.LRK2026-04-17
00850077473760EMA AcrylicEMA SLEEP INCORPORATEDLRK2026-04-14
00850077473777EMA Dual LaminateEMA SLEEP INCORPORATEDLRK2026-04-14
00850077473784EMA CustomEMA SLEEP INCORPORATEDLRK2026-04-14
00850077473807EMA MilledEMA SLEEP INCORPORATEDLRK2026-04-14
D775IBA0Banded HerbstGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBABN0Bonded LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAE0Banded Herbst -RPEGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAEBN0Rpe Bonded LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAER0Banded Herbst-Rpe Remov LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAR0Banded Herbst -Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IIST0Telescopic Herbst SleepGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775INIST0Nylon Herbst SleepGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
00860014652103Itus MouthguardzShinrin-Yoku Traders LLCLRK2026-04-06
00860014652110Itus MouthguardzShinrin-Yoku Traders LLCLRK2026-04-06
00860014652127Itus MouthguardzShinrin-Yoku Traders LLCLRK2026-04-06
00850085577009Serena Fixed HingeSERENA SLEEP SOLUTIONS LLCLRK2026-03-30
D8410491E1TAP 3 EliteOrtho Solutions, LCLRK2026-02-25
D8418053R1Respire Blue+ HardOrtho Solutions, LCLRK2026-02-25
D8418054R1Respire Blue+ Hard/SoftOrtho Solutions, LCLRK2026-02-25