FDA.reportPublic FDA data

KAVA HERBST DUAL LAMINATE

Primary DI
00860008847539
Brand
KAVA HERBST DUAL LAMINATE
Company
APEX DENTAL SLEEP LAB INCORPORATED
Model
LQZ
Device description
A Dental Dual laminate oral appliance intended for mandibular advancement and positioning during sleep therapy for the treatment of snoring and obstructive sleep apnea.
Published
2026-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K182661000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182661000Kava and Kava with HerbstSketchpad Innovations, LLC2019-02-13LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008847539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008847539008600088475398600088475390860008847539

GMDN Terms#

Term, Definition table
TermDefinition
Mandible-repositioning/palate-lifting sleep-disordered breathing orthosisA removable intraoral device designed alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning the lower jaw (mandible), frequently in a downward and forward position, and by elevating the soft palate (soft tissue constituting the back of the roof of the mouth). It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding and by applying pressure to 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.

Contacts#

Phone, Email table
PhoneEmail
6197246040sonnie@apexsleep.com

Regulatory Flags#

DUNS number
059544877
Device count
1
Lot or batch
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008847522KAVA DORSAL DUAL LAMINATELQZ2026-04-14
00860008847508KAVA DORSAL ACRYLICLQZ2026-03-18
00860008847515KAVA HERBST ACRYLICLQZ2026-03-18

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
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
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