FDA.reportPublic FDA data

Anti-snoring, restoration

Primary DI
06972677871556
Brand
Anti-snoring, restoration
Company
Modern Dental Laboratory (DG) Co., Ltd.
Model
154
Published
2020-07-21
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
true

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
06972677871549PrimaryGS10
06972677871556Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972677871549069726778715496972677871549
06972677871556069726778715566972677871556

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
551746187
Device count
2
DM exempt
true
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
true

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
D8418265R1Respire Pink AT EFOrtho Solutions, LCLRK2026-02-25
D8418267R1Respire Pink AT Micro EFOrtho Solutions, LCLRK2026-02-25
00860015164407EMANew Image Dental Laboratory, Inc.LRK2026-02-11
00692121035513SleepRightSplintek Inc.LRK2025-12-17
07540204000275Panthera D-SAD Classic DuoPanthera Dentaire IncLRK2025-11-28
07540204000282Panthera D-SAD X3 DuoPanthera Dentaire IncLRK2025-11-28
00860002336596Itus MouthguardzShinrin-Yoku Traders LLCLRK2025-08-25
00860002336572Itus MouthguardzShinrin-Yoku Traders LLCLRK2025-05-01
00850072689005VitalSleepThe Snore Reliever Company, LLCLRK2025-04-09
00850072689012VitalSleepThe Snore Reliever Company, LLCLRK2025-04-09
DR3064993Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR4032584Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR5023119Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR5032714Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR5044538Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR5071026Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR6022107Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR6037018Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR6037022Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR6062580Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR7006994Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR7050810Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01