FDA.reportPublic FDA data

Ortho-Tain, Inc

Primary DI
D866HCCY40BTO0
Brand
Ortho-Tain, Inc
Company
Ortho-Tain, Inc
Model
HABIT CORRECTOR
Catalog number
HC
Device description
YOUTH HC WITH TAB-ORANGE 6-12
Published
2026-04-01
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
DYOBand, Material, Orthodontic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D866HCCY40BTO0PrimaryHIBCC0

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
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
06974720061372Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-06-03
06974720061396Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-06-03
06974720061402Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-06-03
06974720061419Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-06-03
06974720061426Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-06-03
06974720061259Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-06-02
06974720061266Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-06-02
06974720061273Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-06-02
06974720061280Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-06-02
06974720061297Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-06-02
06974720061303Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-06-02
06974720061310Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-06-02
06974720061327Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-06-02
06974720061334Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-06-02
06974720061341Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-06-02
06974720061358Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-06-02
06974720061365Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-06-02
06974720061389Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-06-02
06974720061198Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061204Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061211Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061228Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061235Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061242Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21