FDA.reportPublic FDA data

SML

Primary DI
D85463725S1
Brand
SML
Company
SELANE PRODUCTS, INC.
Model
63725S
Device description
LAMBERG SLEEP WELL DEVICE
Published
2017-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LQZDevice, Jaw Repositioning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQZDevice, Jaw RepositioningDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D85463725S1PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
066642729
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D85463260S1SML63260S2017-08-04
D85463603AACS1SML63603AACS2017-08-04
D85463603AAO2S1SML63603AAO2S2017-08-04
D85463603AAS1SML63603AAS2017-08-04
D85463603ACO2S1SML63603ACO2S2017-08-04
D85463603ALCS1SML63603ALCS2017-08-04
D85463603AO2S1SML63603AO2S2017-08-04
D85463603AS1SML63603AS2017-08-04
D85463603L1SML63603L2017-08-04
D85463603LS1SML63603LS2017-08-04
D85463603NS1SML63603NS2017-08-04
D85463603PMTS1SML63603PMTS2017-08-04
D85463603WS1SML63603WS2017-08-04
D854620651SML620652020-02-21
D85460994LS1SML60994LS2017-08-04
D85460994S1SML60994S2017-08-04
D85463224S1SML63224S2017-08-04
D85463225AHS1SML63225AHS2017-08-04
D85463225AS1SML63225AS2017-08-04
D85463226S1SML63226S2017-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESLQZ2026-04-24
00860015650405EMADENTAL PROSTHETIC SERVICES, INC.LQZ2026-04-17
00850077473791EMA 3DEMA SLEEP INCORPORATEDLQZ2026-04-14
00860008847522KAVA DORSAL DUAL LAMINATEAPEX DENTAL SLEEP LAB INCORPORATEDLQZ2026-04-14
00860008847539KAVA HERBST DUAL LAMINATEAPEX DENTAL SLEEP LAB INCORPORATEDLQZ2026-04-14
D775CSAA0NAPA ApplianceGreat Lakes Dental Technologies, Ltd.LQZ2026-04-13
00860008847508KAVA DORSAL ACRYLICAPEX DENTAL SLEEP LAB INCORPORATEDLQZ2026-03-18
00860008847515KAVA HERBST ACRYLICAPEX DENTAL SLEEP LAB INCORPORATEDLQZ2026-03-18
DR3064993Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLQZ2025-04-01
DR4032584Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLQZ2025-04-01
DR5023119Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLQZ2025-04-01
DR5032714Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLQZ2025-04-01
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DR7050810Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLQZ2025-04-01
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DR7070153Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLQZ2025-04-01
DR7070154Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLQZ2025-04-01
DR7081395Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLQZ2025-04-01
DR7081396Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLQZ2025-04-01
DR8017868Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLQZ2025-04-01
DR8017869Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLQZ2025-04-01
DR8017883Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLQZ2025-04-01
DR8017910Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLQZ2025-04-01