FDA.reportPublic FDA data

Ortho-Tain, Inc

Primary DI
D866SC0
Brand
Ortho-Tain, Inc
Company
Ortho-Tain, Inc
Model
SNORE CURE
Catalog number
00S
Device description
SNORE CURE
Published
2022-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
D866SC0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic retainerAn orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

Regulatory Flags#

DUNS number
090557638
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D866HCCP40BPB0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCP40BPG0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCP40BPO0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCP40BPP0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCP40BPPK0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCP40BPTB0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCP40BPTG0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCP40BPTO0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCP40BPTP0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCP40BPTPK0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCP40BTB0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCP40BTG0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCP40BTO0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCP40BTP0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCP40BTPK0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCSA40ANB0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCSK40APB0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCSK40APG0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCSK40APO0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01
D866HCCSK40APP0Ortho-Tain, IncHABIT CORRECTORHC2026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860005753093Serena SureSERENA SLEEP SOLUTIONS LLCLRK2026-05-20
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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