FDA.reportPublic FDA data

Respire Blue+ EF

Primary DI
D8418056R1
Brand
Respire Blue+ EF
Company
Ortho Solutions, LC
Model
1
Published
2026-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K152292000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152292000Respire Blue Series-EFRespire Medical Holding2015-12-07LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8418056R1PrimaryHIBCC0

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
006335558
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D841300R8151Clearviz Mini300-R8-2026-05-14
D841300R81511Clearviz Mini300-R8-2026-05-14
D841300R8211Clearviz Mini300-R8-2026-05-14
D841300R8221Clearviz Mini300-R8-2026-05-14
D841300R82311Clearviz Mini300-R8-2026-05-14
D841300R8241Clearviz Mini300-R8-2026-05-14
D841300R82411Clearviz Mini300-R8-2026-05-14
D841300R8251Clearviz Mini300-R8-2026-05-14
D841300R82511Clearviz Mini300-R8-2026-05-14
D841300R831Clearviz Mini300-R8-2026-05-14
D841300R8311Clearviz Mini300-R8-2026-05-14
D841300R83311Clearviz Mini300-R8-2026-05-14
D841300R8341Clearviz Mini300-R8-2026-05-14
D841300R83411Clearviz Mini300-R8-2026-05-14
D841300R83451Clearviz Mini300-R8-2026-05-14
D841300R8351Clearviz Mini300-R8-2026-05-14
D841300R83511Clearviz Mini300-R8-2026-05-14
D841300R84311Clearviz Mini300-R8-2026-05-14
D841300R8441Clearviz Mini300-R8-2026-05-14
D841300R84411Clearviz Mini300-R8-2026-05-14

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