FDA.reportPublic FDA data

Orchestrate 3D

Primary DI
00860008123404
Brand
Orchestrate 3D
Company
Orchestrate 3d
Model
1
Device description
Orthodontic Software
Published
2022-06-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00860008123404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008123404008600081234048600081234040860008123404

GMDN Terms#

Term, Definition table
TermDefinition
Dental milling system, CAD/CAM, chairsideAn assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for the production of the actual devices to be fitted to the patient.

Regulatory Flags#

DUNS number
054153356
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816063022305Invisalign System with Integrated ButtonsAlign Technology, Inc.PNN2026-09-29
00816063023418Invisalign Palatal Expander with Engagement FeaturesAlign Technology, Inc.PNN2026-09-29
00816063023425Invisalign Palatal Holder with Engagement FeaturesAlign Technology, Inc.PNN2026-09-29
00860002991078Brius PlannerBrius Technologies IncPNN2026-06-05
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
00860002380087uLab Systems uDesignUlab Systems, Inc.PNN2022-04-11