Emerald Herbst

Primary DI
DRB063867
Brand
Emerald Herbst
Company
Island Dental Lab Inc. DBA Emerald Dental Lab
Model
Emerald Herbst
Device description
The Emerald Herbst appliance is a customized oral device featuring both lower and upper trays and interlocking system. The product is non-sterile, biocompatible, and provided in a sealed box with instructions for use. The upper and lower trays are connected by an adjustable hinge allowing the patient to open and close the mouth while wearing the appliance. The Herbst Telescopic Hardware on the side of the device allows the patient to move forward and left and right but not backwards. This freedom of movement is important for comfort and overall success of the device. The Emerald Herbst appliance treats snoring and mild to moderate sleep apnea by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway.
Published
2025-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LRKDevice, Anti-Snoring

Product Code Classifications

CodeDeviceSpecialtyClass
LRKDevice, Anti-SnoringDental2

Premarket Submissions

SubmissionSupplement
K223624000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K223624000Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental2023-05-10LRK

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
DRB063867PrimaryHIBCC0

GMDN Terms

TermDefinition
Mandible-repositioning/palate-lifting sleep-disordered breathing orthosisA removable intraoral device designed alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning the lower jaw (mandible), frequently in a downward and forward position, and by elevating the soft palate (soft tissue constituting the back of the roof of the mouth). It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding and by applying pressure to lift a drooping soft palate, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
111807817
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
DR3064993Emerald HerbstEmerald Herbst2025-04-01
DR4032584Emerald HerbstEmerald Herbst2025-04-01
DR5023119Emerald HerbstEmerald Herbst2025-04-01
DR5032714Emerald HerbstEmerald Herbst2025-04-01
DR5044538Emerald HerbstEmerald Herbst2025-04-01
DR5071026Emerald HerbstEmerald Herbst2025-04-01
DR6022107Emerald HerbstEmerald Herbst2025-04-01
DR6037018Emerald HerbstEmerald Herbst2025-04-01
DR6037022Emerald HerbstEmerald Herbst2025-04-01
DR6062580Emerald HerbstEmerald Herbst2025-04-01
DR7006994Emerald HerbstEmerald Herbst2025-04-01
DR7050810Emerald HerbstEmerald Herbst2025-04-01
DR7050811Emerald HerbstEmerald Herbst2025-04-01
DR7051365Emerald HerbstEmerald Herbst2025-04-01
DR7070153Emerald HerbstEmerald Herbst2025-04-01
DR7070154Emerald HerbstEmerald Herbst2025-04-01
DR7081395Emerald HerbstEmerald Herbst2025-04-01
DR7081396Emerald HerbstEmerald Herbst2025-04-01
DR8017868Emerald HerbstEmerald Herbst2025-04-01
DR8017869Emerald HerbstEmerald Herbst2025-04-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
D8410491E1TAP 3 EliteOrtho Solutions, LCLRK2026-02-25
D8418053R1Respire Blue+ HardOrtho Solutions, LCLRK2026-02-25
D8418054R1Respire Blue+ Hard/SoftOrtho Solutions, LCLRK2026-02-25
D8418056R1Respire Blue+ EFOrtho Solutions, LCLRK2026-02-25
D8418260R1Respire Pink AT HardOrtho Solutions, LCLRK2026-02-25
D8418261R1Respire Pink AT Hard/SoftOrtho Solutions, LCLRK2026-02-25
D8418262R1Respire Pink AT Micro HardOrtho Solutions, LCLRK2026-02-25
D8418263R1Respire Pink AT Micro Hard/SoftOrtho Solutions, LCLRK2026-02-25
D8418265R1Respire Pink AT EFOrtho Solutions, LCLRK2026-02-25
D8418267R1Respire Pink AT Micro EFOrtho Solutions, LCLRK2026-02-25
00860015164407EMANew Image Dental Laboratory, Inc.LRK2026-02-11
00692121035513SleepRightSplintek Inc.LRK2025-12-17
07540204000275Panthera D-SAD Classic DuoPanthera Dentaire IncLRK2025-11-28
07540204000282Panthera D-SAD X3 DuoPanthera Dentaire IncLRK2025-11-28
00860002336596Itus MouthguardzShinrin-Yoku Traders LLCLRK2025-08-25
00860002336572Itus MouthguardzShinrin-Yoku Traders LLCLRK2025-05-01
00850072689005VitalSleepThe Snore Reliever Company, LLCLRK2025-04-09
00850072689012VitalSleepThe Snore Reliever Company, LLCLRK2025-04-09
DR3064993Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR4032584Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR5023119Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR5032714Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR5044538Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR5071026Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR6022107Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR6037018Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR6037022Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR6062580Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR7006994Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR7050810Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01