FDA.reportPublic FDA data

EMA 3D PATIENT STARTER KITS

Primary DI
00850077473029
Brand
EMA 3D PATIENT STARTER KITS
Company
EMA SLEEP INCORPORATED
Model
EMA 3D
Catalog number
EMAST10B
Device description
An elastic intra-oral appliance strap used with mandibular advancement devices to adjust and maintain lower jaw positioning during sleep therapy for the treatment of snoring and obstructive sleep apnea.
Published
2026-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00850077473029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850077473029008500774730298500774730290850077473029

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00850077473210Individual EMA Straps(EMAST21Y)EMA 21 YELLOWEMAST21Y2026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860008847539KAVA HERBST DUAL LAMINATEAPEX DENTAL SLEEP LAB INCORPORATEDLQZ2026-04-14
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00860008847515KAVA HERBST ACRYLICAPEX DENTAL SLEEP LAB INCORPORATEDLQZ2026-03-18
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