FDA.reportPublic FDA data

Ortho-Tain, Inc

Primary DI
D866HCCY40BTB0
Brand
Ortho-Tain, Inc
Company
Ortho-Tain, Inc
Model
HABIT CORRECTOR
Catalog number
HC
Device description
YOUTH HC WITH TAB-BLUE 6-12
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
D866HCCY40BTB0PrimaryHIBCC0

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
06974720061556Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061563Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061570Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061587Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061594Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061600Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061679Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061686Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061693Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061709Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061716Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061723Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061792Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061808Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061815Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061822Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061839Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061846Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061853Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061860Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061877Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061884Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061891Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061907Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-17
06974720061495Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-13
06974720061501Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-13
06974720061518Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-13
06974720061525Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-13
06974720061532Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-13
06974720061549Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-07-13