FDA.reportPublic FDA data

Angel Aligner

Primary DI
06977207040662
Brand
Angel Aligner
Company
Shanghai EA Medical Instruments Co., Ltd.
Model
iOrtho
Published
2026-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06977207040662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977207040662069772070406626977207040662

GMDN Terms#

Term, Definition table
TermDefinition
CAD/CAM softwareA software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals.

Regulatory Flags#

DUNS number
544344306
Device count
1

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
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
00850018135030InBrace Teeth Straightening System (Gen 2.0)SWIFT HEALTH SYSTEMS INC.PNN2021-11-07