FDA.reportPublic FDA data

Ortho-Tain, Inc

Primary DI
D866HCCY40BPTP0
Brand
Ortho-Tain, Inc
Company
Ortho-Tain, Inc
Model
HABIT CORRECTOR
Catalog number
HC
Device description
YOUTH HC PADS & PULL TAB-PURPLE
Published
2026-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYOBand, Material, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYOBand, Material, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D866HCCY40BPTP0PrimaryHIBCC0

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
Premarket 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
06974720064014Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-09-24
06974720064021Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-09-24
06974720064038Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-09-24
06974720064045Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-09-24
06974720064052Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-09-24
06974720064069Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-09-24
06974720063796Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-09-18
06974720063802Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-09-18
06974720063819Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-09-18
06974720063826Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-09-18
06974720063833Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-09-18
06974720063840Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-09-18
06974720063857Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-09-18
06974720063864Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-09-18
06974720063871Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-09-18
06974720063888Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-09-18
06974720063895Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-09-18
06974720063901Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-09-18
06974720063611Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-08-19
06974720063628Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-08-19
06974720063635Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-08-19
06974720063642Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-08-19
06974720063659Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-08-19
06974720063666Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-08-19
06974720063499Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-08-18
06974720063505Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-08-18
06974720063512Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-08-18
06974720063529Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-08-18
06974720063536Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-08-18
06974720063543Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-08-18