FDA.reportPublic FDA data

EMA 3D

Primary DI
00850077473791
Brand
EMA 3D
Company
EMA SLEEP INCORPORATED
Model
LQZ
Device description
An intra 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
K232735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232735000EMA 3DEma Sleep Incorporated2024-05-03LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850077473791PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850077473791008500774737918500774737910850077473791

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.

Contacts#

Phone, Email table
PhoneEmail
5125857861joe@ema-sleep.com

Regulatory Flags#

DUNS number
100648767
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850077473760EMA AcrylicLRK2026-04-14
00850077473777EMA Dual LaminateLRK2026-04-14
00850077473784EMA CustomLRK2026-04-14
00850077473807EMA MilledLRK2026-04-14

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
00860008847522KAVA DORSAL DUAL LAMINATEAPEX DENTAL SLEEP LAB INCORPORATEDLQZ2026-04-14
00860008847539KAVA HERBST 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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