FDA.reportPublic FDA data

Bonded Lower

Primary DI
D775IBABN0
Brand
Bonded Lower
Company
Great Lakes Dental Technologies, Ltd.
Model
IBABN
Published
2026-04-13
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
D775IBABN0PrimaryHIBCC0

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
D775IBNER0Bonded Herbst - RPE Removable LowerIBNER2026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850077473005EMA NOW PATIENT STARTER KITSEMA SLEEP INCORPORATEDLRK2026-08-14
00850077473012EMA Serena Patient Starter kitsEMA SLEEP INCORPORATEDLRK2026-08-14
00850077473043INDIVIDUAL EMA STRAPS(EMAST13W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473050Individual EMA Straps(EMAST14W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473067Individual EMA Straps(EMAST15W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473074Individual EMA Straps(EMAST16W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473081Individual EMA Straps(EMAST17W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473098Individual EMA Straps(EMAST18W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473104Individual EMA Straps(EMAST19W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473111Individual EMA Straps(EMAST20W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473128Individual EMA Straps(EMAST21W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473135Individual EMA Straps(EMAST13Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473142Individual EMA Straps(EMAST14Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473159Individual EMA Straps(EMAST15Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473166Individual EMA Straps(EMAST16Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473173Individual EMA Straps(EMAST17Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473180Individual EMA Straps(EMAST18Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473197Individual EMA Straps(EMAST19Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473203Individual EMA Straps(EMAST20Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473210Individual EMA Straps(EMAST21Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473227Individual EMA Straps(EMAST13B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473234Individual EMA Straps(EMAST14B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473241Individual EMA Straps(EMAST15B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473258Individual EMA Straps(EMAST16B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473265Individual EMA Straps(EMAST17B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473272Individual EMA Straps(EMAST18B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473289Individual EMA Straps(EMAST19B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473296Individual EMA Straps(EMAST20B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473302Individual EMA Straps(EMAST21B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473319Individual EMA Straps(EMAST13C)EMA SLEEP INCORPORATEDLRK2026-08-14