FDA.reportPublic FDA data

Bonded Herbst - RPE Removable Lower

Primary DI
D775IBNER0
Brand
Bonded Herbst - RPE Removable Lower
Company
Great Lakes Dental Technologies, Ltd.
Model
IBNER
Published
2026-05-07
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
K955822000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955822000REMOVABLE HERBST APPLIANCEUniv. Dental Assoc. Department of Orthodontics1996-03-20LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D775IBNER0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Palate-lifting sleep-disordered breathing orthosisA removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by elevating the soft palate (soft tissue constituting the back of the roof of the mouth). It works by applying pressure to retract and 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.

Regulatory Flags#

DUNS number
041854332
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D775AHAD0Hawley Retainer with Adams ClaspsAHAD2026-05-10
D775AHAR0Hawley Retainer with Arrow ClaspsAHAR2026-05-10
D775AHBC0Hawley Retainer with Ball ClaspsAHBC2026-05-10
D775AHCC0Hawley Retainer with Circumferential ClaspsAHCC2026-05-10
D775BMARPEL0MARPEBMARPEL2026-05-10
D775BMARPEP0MARPEBMARPEP2026-05-10
D775BMMT0MemotainBMMT2026-05-10
D775JFP0Splint - Flat PlaneJFP2026-05-10
D775JFPRS0Rhea Flat Plane SplintJFPRS2026-05-10
D775JNFP0Nylon Flat Plane SplintJNFP2026-05-10
D77595102Smart Moves Complete Phase 1 Trays9512026-05-07
D775AASS0Super Spring AlignerAASS2026-05-07
D775ABLR0Bloore Removable AlignerABLR2026-05-07
D775AII0Invisible Inman AlignerAII2026-05-07
D775ALIA0Lower Inman AlignerALIA2026-05-07
D775ALIAW0Lower Inman Aligner 'Wireless' ALIAW2026-05-07
D775IBASA0Herbst -Banded Upper Or Lower-Single ArchIBASA2026-05-07
D775IBN0Bonded HerbstIBN2026-05-07
D775IBNE0Bonded Herbst - RPEIBNE2026-05-07
D775IBNR0Bonded Herbst-Removable LowerIBNR2026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
D8418056R1Respire Blue+ EFOrtho Solutions, LCLRK2026-02-25
D8418260R1Respire Pink AT HardOrtho Solutions, LCLRK2026-02-25