Ortho-Tain, Inc

Primary DI
D866N42000
Brand
Ortho-Tain, Inc
Company
Ortho-Tain, Inc
Model
ORTHO TAIN POSITIONER
Catalog number
N4200NT
Device description
ORTHO-TAIN ORTHO-T
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
ECMBand, Preformed, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECMBand, Preformed, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D866N42000PrimaryHIBCC0

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
08033707035763LEONE SPALEONE SPAECM2020-11-11
08033707035770LEONE SPALEONE SPAECM2020-11-11
08033707035787LEONE SPALEONE SPAECM2020-11-11
08033707035794LEONE SPALEONE SPAECM2020-11-11
08033707035800LEONE SPALEONE SPAECM2020-11-11
08033707035817LEONE SPALEONE SPAECM2020-11-11
08033707035824LEONE SPALEONE SPAECM2020-11-11
08033707035831LEONE SPALEONE SPAECM2020-11-11
08033707035848LEONE SPALEONE SPAECM2020-11-11
08033707035855LEONE SPALEONE SPAECM2020-11-11
08033707035862LEONE SPALEONE SPAECM2020-11-11
08033707035879LEONE SPALEONE SPAECM2020-11-11
08033707035886LEONE SPALEONE SPAECM2020-11-11
08033707035893LEONE SPALEONE SPAECM2020-11-11
08033707035909LEONE SPALEONE SPAECM2020-11-11
08033707035916LEONE SPALEONE SPAECM2020-11-11
08033707035923LEONE SPALEONE SPAECM2020-11-11
08033707035930LEONE SPALEONE SPAECM2020-11-11
08033707035947LEONE SPALEONE SPAECM2020-11-11
08033707035954LEONE SPALEONE SPAECM2020-11-11
08033707035961LEONE SPALEONE SPAECM2020-11-11
08033707035978LEONE SPALEONE SPAECM2020-11-11
08033707035985LEONE SPALEONE SPAECM2020-11-11
08033707035992LEONE SPALEONE SPAECM2020-11-11
08033707036005LEONE SPALEONE SPAECM2020-11-11
08033707036012LEONE SPALEONE SPAECM2020-11-11
08033707036029LEONE SPALEONE SPAECM2020-11-11
08033707036036LEONE SPALEONE SPAECM2020-11-11
08033707036043LEONE SPALEONE SPAECM2020-11-11
08033707036050LEONE SPALEONE SPAECM2020-11-11