FDA.reportPublic FDA data

Inbrace Teeth Straightening System

Primary DI
00850018135139
Brand
Inbrace Teeth Straightening System
Company
SWIFT HEALTH SYSTEMS INC.
Model
Lower Patient Kit
Catalog number
8121
Published
2021-11-07
Public version status
Update
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
PNNOrthodontic Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNNOrthodontic SoftwareDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018135139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018135139008500181351398500181351390850018135139

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
884398210
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018135122Inbrace Teeth Straightening System Digital Engancement81312022-10-03
00850018135009Inbrace Teeth Straightening System Standard Patient Kit81012021-11-07
00850018135016Inbrace Teeth Straightening System Upper Patient Kit81112021-11-07
00850018135030InBrace Teeth Straightening System (Gen 2.0)Upper Fitting Kit850022021-11-07
00850018135047InBrace Teeth Straightening System (Gen 2.0)Fitting Kit850002021-11-07
00850018135054InBrace Teeth Straightening System (Gen 2.0)Lower Fitting Kit850032021-11-07
10850018135396InBrace Starter Kit 83000830002021-11-24
00850018135399Smartwire InGager85001850012021-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D775BMARPEL0MARPEGreat Lakes Dental Technologies, Ltd.PNN2026-05-10
D775BMARPEP0MARPEGreat Lakes Dental Technologies, Ltd.PNN2026-05-10
06977207040662Angel AlignerShanghai EA Medical Instruments Co., Ltd.PNN2026-05-08
08437023642016NemoCastSOFTWARE NEMOTEC SLPNN2026-04-23
00810060227053Blue Sky Bio, LLC.BLUE SKY BIO LLCPNN2026-04-13
00860012168521Archform Orthodontic SoftwareArchform Inc.PNN2025-07-22
D769O3D0Orchestrate 3DPARK DENTAL RESEARCH CORPPNN2025-07-17
08800026700869Medit Orthodontic SuiteMedit Corp.PNN2025-05-29
D16420251Progressive Orthodontics AppPROGRESSIVE AMERICA, INC.PNN2025-04-30
00810060226346Blue Sky Bio, LLC.BLUE SKY BIO LLCPNN2025-02-20
00860461001776uLab Systems uDesignUlab Systems, Inc.PNN2025-01-28
D16409625Progressive Orthodontics AppPROGRESSIVE AMERICA, INC.PNN2024-11-07
00810060226063Blue Sky Bio, LLC.BLUE SKY BIO LLCPNN2024-06-19
08800003005031RAYDENT SWRay Co., LtdPNN2024-05-23
00860461001783uLab Systems uDesignUlab Systems, Inc.PNN2024-05-20
00860009273702VisionSoftsmile, Inc.PNN2024-02-16
05902729753913Automate3shape A/SPNN2024-01-22
00816063021384Invisalign Palatal HolderAlign Technology, Inc.PNN2024-01-03
00816063021391Invisalign Palatal ExpanderAlign Technology, Inc.PNN2024-01-03
D981ONYXCEPH320OnyxCeph³Image Instruments GmbHPNN2024-01-02
00693856000302CS MODEL+Dental Imaging Technologies CorporationPNN2023-12-13
00860011071921Arcad AlignersARCADLABPNN2023-11-17
00860461001769uLab Systems uDesignUlab Systems, Inc.PNN2023-11-02
05902729753821Automate3shape A/SPNN2023-03-28
00850018135122Inbrace Teeth Straightening System SWIFT HEALTH SYSTEMS INC.PNN2022-10-03
00860008123404Orchestrate 3D Orchestrate 3dPNN2022-06-21
00860002380087uLab Systems uDesignUlab Systems, Inc.PNN2022-04-11
00816063021360ClinCheckAlign Technology, Inc.PNN2022-02-17
00850018135009Inbrace Teeth Straightening System SWIFT HEALTH SYSTEMS INC.PNN2021-11-07
00850018135016Inbrace Teeth Straightening System SWIFT HEALTH SYSTEMS INC.PNN2021-11-07