FDA.reportPublic FDA data

The Moses TM Appliance

Primary DI
06972677870023
Brand
The Moses TM Appliance
Company
Modern Dental Laboratory (DG) Co., Ltd.
Model
002
Device description
The Moses appliance is intended for use on adult patients 18 years of age and older as an aid for the reduction and /or alleviation of snoring and mild to moderate obstrctive sleep apnea.
Published
2019-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
06972677870023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972677870023069726778700236972677870023

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
551746187
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
06972677870214Trioclear System S,H2023-09-04
06972677870221Trioclear SystemS2023-09-04
06972677870238Trioclear SystemH2023-09-04
06972677870207Orthodontic Appliance0202023-08-08
06972677870191Respire Pink AT Series0192022-09-19
06972677871877Respire Pink AT Series,Retainer1862022-09-19
06972677871891Respire Pink AT Series,Splint1882022-09-19
06972677870153Blue Series0152022-08-26
06972677870160Pink Series0162022-08-26
06972677870177Blue EF Series0172022-08-26
06972677870184Pink EF Series0182022-08-26
06972677871730Pink Series,Retainer1722022-08-26
06972677871754Blue EF Series,Retainer1742022-08-26
06972677871778Pink EF Series,Retainer1762022-08-26
06972677871792Blue Series,Splint1782022-08-26
06972677871815Pink Series,Splint1802022-08-26
06972677871839Blue EF Series,Splint1822022-08-26
06972677871853Pink EF Series,Splint1842022-08-26
06972677871662Moses appliance,Dentures, partial1662022-08-18
06972677871693EMA appliance,Dentures, partial1682022-08-18

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D8418056R1Respire Blue+ EFOrtho Solutions, LCLRK2026-02-25
D8418260R1Respire Pink AT HardOrtho Solutions, LCLRK2026-02-25
D8418261R1Respire Pink AT Hard/SoftOrtho Solutions, LCLRK2026-02-25
D8418262R1Respire Pink AT Micro HardOrtho Solutions, LCLRK2026-02-25
D8418263R1Respire Pink AT Micro Hard/SoftOrtho Solutions, LCLRK2026-02-25
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