Home GUDID 00810002220036
EMA (Elastic Mandibular Appliance)
Primary DI 00810002220036
Brand EMA (Elastic Mandibular Appliance)
Company JOHN'S DENTAL LABORATORY INC
Model 3014680794
Device description A 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.
Published 2020-09-23
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true Product Codes# Code, Name table Code Name LQZ Device, Jaw Repositioning LRK Device, Anti-Snoring LWF Dilator, Nasal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LQZ Device, Jaw Repositioning Dental 2 LRK Device, Anti-Snoring Dental 2 LWF Dilator, Nasal Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810002220036 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810002220036 00810002220036 810002220036 0810002220036
GMDN Terms# Term, Definition table Term Definition Mandible-repositioning sleep-disordered breathing orthosis A 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.
Regulatory Flags# DUNS number 016649253 Device count 1 Combination product true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published D854413871967328267319 ApnoDent SELANE PRODUCTS, INC. LRK 2026-05-29 00860005753093 Serena Sure SERENA SLEEP SOLUTIONS LLC LRK 2026-05-20 00850040983111 WoodyKnows M&M Pure Air Systems LLC LWF 2026-05-19 00850040983128 WoodyKnows M&M Pure Air Systems LLC LWF 2026-05-19 00850040983135 WoodyKnows M&M Pure Air Systems LLC LWF 2026-05-19 00850040983142 WoodyKnows M&M Pure Air Systems LLC LWF 2026-05-19 00851085006247 Nylon flexTAP Oral Appliance AIRWAY TECHNOLOGIES, LLC LRK 2026-05-08 00851085006254 Nylon flexTAP Oral Appliance Kit AIRWAY TECHNOLOGIES, LLC LRK 2026-05-08 D775IBASA0 Herbst -Banded Upper Or Lower-Single Arch Great Lakes Dental Technologies, Ltd. LRK 2026-05-07 D775IBN0 Bonded Herbst Great Lakes Dental Technologies, Ltd. LRK 2026-05-07 D775IBNE0 Bonded Herbst - RPE Great Lakes Dental Technologies, Ltd. LRK 2026-05-07 D775IBNER0 Bonded Herbst - RPE Removable Lower Great Lakes Dental Technologies, Ltd. LRK 2026-05-07 D775IBNR0 Bonded Herbst-Removable Lower Great Lakes Dental Technologies, Ltd. LRK 2026-05-07 00850022853036 ProSomnus RPMO2 OSA Device PROSOMNUS SLEEP TECHNOLOGIES LRK 2026-04-24 00850022853036 ProSomnus RPMO2 OSA Device PROSOMNUS SLEEP TECHNOLOGIES LQZ 2026-04-24 00860015650405 EMA DENTAL PROSTHETIC SERVICES, INC. LRK 2026-04-17 00860015650405 EMA DENTAL PROSTHETIC SERVICES, INC. LQZ 2026-04-17 00850077473760 EMA Acrylic EMA SLEEP INCORPORATED LRK 2026-04-14 00850077473777 EMA Dual Laminate EMA SLEEP INCORPORATED LRK 2026-04-14 00850077473784 EMA Custom EMA SLEEP INCORPORATED LRK 2026-04-14 00850077473791 EMA 3D EMA SLEEP INCORPORATED LQZ 2026-04-14 00850077473807 EMA Milled EMA SLEEP INCORPORATED LRK 2026-04-14 00860008847522 KAVA DORSAL DUAL LAMINATE APEX DENTAL SLEEP LAB INCORPORATED LQZ 2026-04-14 00860008847539 KAVA HERBST DUAL LAMINATE APEX DENTAL SLEEP LAB INCORPORATED LQZ 2026-04-14 D775CSAA0 NAPA Appliance Great Lakes Dental Technologies, Ltd. LQZ 2026-04-13 D775IBA0 Banded Herbst Great Lakes Dental Technologies, Ltd. LRK 2026-04-13 D775IBABN0 Bonded Lower Great Lakes Dental Technologies, Ltd. LRK 2026-04-13 D775IBAE0 Banded Herbst -RPE Great Lakes Dental Technologies, Ltd. LRK 2026-04-13 D775IBAEBN0 Rpe Bonded Lower Great Lakes Dental Technologies, Ltd. LRK 2026-04-13 D775IBAER0 Banded Herbst-Rpe Remov Lower Great Lakes Dental Technologies, Ltd. LRK 2026-04-13