FDA.reportPublic FDA data

NAPA Appliance

Primary DI
D775CSAA0
Brand
NAPA Appliance
Company
Great Lakes Dental Technologies, Ltd.
Model
CSAA
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
LQZDevice, Jaw Repositioning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQZDevice, Jaw RepositioningDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K902790000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902790000NAPAG-Ortho Lab1990-09-19LQZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D775CSAA0PrimaryHIBCC0

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
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
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
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DR6037018Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLQZ2025-04-01
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DR7006994Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLQZ2025-04-01
DR7050810Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLQZ2025-04-01
DR7050811Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLQZ2025-04-01
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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
DR8017930Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLQZ2025-04-01