FDA.reportPublic FDA data

EMA Dual Laminate

Primary DI
00850077473777
Brand
EMA Dual Laminate
Company
EMA SLEEP INCORPORATED
Model
LRK
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
LRKDevice, Anti-Snoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRKDevice, Anti-SnoringDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850077473777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850077473777008500774737778500774737770850077473777

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
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850077473005EMA NOW PATIENT STARTER KITSEMA NOWEMAST12Y2026-08-14
00850077473012EMA Serena Patient Starter kitsEMA SERENAEMAST6B2026-08-14
00850077473029EMA 3D PATIENT STARTER KITSEMA 3DEMAST10B2026-08-14
00850077473043INDIVIDUAL EMA STRAPS(EMAST13W)EMA 13 WHITEEMAST13W2026-08-14
00850077473050Individual EMA Straps(EMAST14W)EMA 14 WHITEEMAST14W2026-08-14
00850077473067Individual EMA Straps(EMAST15W)EMA 15 WHITEEMAST15W2026-08-14
00850077473074Individual EMA Straps(EMAST16W)EMA 16 WHITEEMAST16W2026-08-14
00850077473081Individual EMA Straps(EMAST17W)EMA 17 WHITEEMAST17W2026-08-14
00850077473098Individual EMA Straps(EMAST18W)EMA 18 WHITEEMAST18W2026-08-14
00850077473104Individual EMA Straps(EMAST19W)EMA 19 WHITEEMAST19W2026-08-14
00850077473111Individual EMA Straps(EMAST20W)EMA 20 WHITEEMAST20W2026-08-14
00850077473128Individual EMA Straps(EMAST21W)EMA 21 WHITEEMAST21W2026-08-14
00850077473135Individual EMA Straps(EMAST13Y)EMA 13 YELLOWEMAST13Y2026-08-14
00850077473142Individual EMA Straps(EMAST14Y)EMA 14 YELLOWEMAST14Y2026-08-14
00850077473159Individual EMA Straps(EMAST15Y)EMA 15 YELLOWEMAST15Y2026-08-14
00850077473166Individual EMA Straps(EMAST16Y)EMA 16 YELLOWEMAST16Y2026-08-14
00850077473173Individual EMA Straps(EMAST17Y)EMA 17 YELLOWEMAST17Y2026-08-14
00850077473180Individual EMA Straps(EMAST18Y)EMA 18 YELLOWEMAST18Y2026-08-14
00850077473197Individual EMA Straps(EMAST19Y)EMA 19 YELLOWEMAST19Y2026-08-14
00850077473203Individual EMA Straps(EMAST20Y)EMA 20 YELLOWEMAST20Y2026-08-14

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