FDA.reportPublic FDA data

EMA Custom

Primary DI
00842326101135
Brand
EMA Custom
Company
The Myerson Company Limited
Model
EMADISC-NTL-98-20
Device description
EMA CAD Disc, 98mm x 20mm thick, opaque
Published
2020-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRKDevice, Anti-Snoring

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971794000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971794000ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCEFrantz Design, Inc.1997-09-29LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842326101135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842326101135008423261011358423261011350842326101135

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height20Millimeter
Outer Diameter98Millimeter

Contacts#

Phone, Email table
PhoneEmail
18004232683orders@myersontooth.com

Regulatory Flags#

DUNS number
857278431
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842326128095DuraflexDF-DPC-MD-6PK2026-05-26
00842326128101DuraflexDF-MPC-MD-6PK2026-05-26
00842326128118DuraflexDF-PNC-MD-6PK2026-05-26
00842326128125DuraflexDF-TTC-MD-6PK2026-05-26
00842326199620Trusana1TRUJR-U12025-10-24
00842326104693DuraflexDFDISC-NP-98-202025-09-04
00842326104709DuraflexDFDISC-NP-98-252025-09-04
00842326199460TrusanaTRU405-LTPNK-TRI2025-08-26
00842326199477TrusanaTRU405-DKPNK-TRI2025-08-26
00842326199484TrusanaTRU405-A1-N-TRI2025-08-26
00842326199491TrusanaTRU405-A2-N-TRI2025-08-26
00842326199507TrusanaTRU405-A3-N-TRI2025-08-26
00842326199514TrusanaTRU405-B1-N-TRI2025-08-26
00842326199521TrusanaTRU405-B2-N-TRI2025-08-26
00842326199538TrusanaTRU405-51-N-TRI2025-08-26
00842326104235VisiclearVCDISCB-98-152018-08-09
00842326104242VisiclearVCDISCB-98-202018-08-09
00842326199576Trusana1TRUJR-A12025-02-28
00842326199583Trusana1TRUJR-A22025-02-28
00842326199590Trusana1TRUJR-A32025-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00851085006254Nylon flexTAP Oral Appliance KitAIRWAY TECHNOLOGIES, LLCLRK2026-05-08
D775IBASA0Herbst -Banded Upper Or Lower-Single ArchGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBN0Bonded HerbstGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBNE0Bonded Herbst - RPEGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBNER0Bonded Herbst - RPE Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBNR0Bonded Herbst-Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESLRK2026-04-24
00860015650405EMADENTAL PROSTHETIC SERVICES, INC.LRK2026-04-17
00850077473760EMA AcrylicEMA SLEEP INCORPORATEDLRK2026-04-14
00850077473777EMA Dual LaminateEMA SLEEP INCORPORATEDLRK2026-04-14
00850077473784EMA CustomEMA SLEEP INCORPORATEDLRK2026-04-14
00850077473807EMA MilledEMA SLEEP INCORPORATEDLRK2026-04-14
D775IBA0Banded HerbstGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBABN0Bonded LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAE0Banded Herbst -RPEGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAEBN0Rpe Bonded LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAER0Banded Herbst-Rpe Remov LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAR0Banded Herbst -Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IIST0Telescopic Herbst SleepGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775INIST0Nylon Herbst SleepGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
00860014652103Itus MouthguardzShinrin-Yoku Traders LLCLRK2026-04-06
00860014652110Itus MouthguardzShinrin-Yoku Traders LLCLRK2026-04-06
00860014652127Itus MouthguardzShinrin-Yoku Traders LLCLRK2026-04-06
00850085577009Serena Fixed HingeSERENA SLEEP SOLUTIONS LLCLRK2026-03-30
D8410491E1TAP 3 EliteOrtho Solutions, LCLRK2026-02-25
D8418053R1Respire Blue+ HardOrtho Solutions, LCLRK2026-02-25
D8418054R1Respire Blue+ Hard/SoftOrtho Solutions, LCLRK2026-02-25
D8418056R1Respire Blue+ EFOrtho Solutions, LCLRK2026-02-25