FDA.reportPublic FDA data

Medit Orthodontic Suite

Primary DI
08800026700869
Brand
Medit Orthodontic Suite
Company
Medit Corp.
Model
2.0
Published
2025-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
PNNOrthodontic Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
PNNOrthodontic SoftwareDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800026700869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800026700869088000267008698800026700869

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688800085
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800026700890Medit AuraVueMA-AAV2026-05-11
08800026700760Medit Link ExpressML-EXP0012026-04-28
08800026700883Medit Link ExpressML-EXP0022026-04-28
08800026700302Reusable Tip (Medium)MO1-RTM2024-04-09
08800026700319 Reusable Tip (Large) MO1-RTL2024-04-09
08800026700395 Reusable Tip (Small)MO1-RTS2024-04-09
08800026700876i900 Series Single Use TipMO1-ST12026-02-03
18800026700873i900 Series Single Use TipMO1-ST12026-02-03
08800026700630i900 MobilityMO3-i900M2025-07-25
08800026700623i900 classicMO4-i900c2025-05-22
08800026700203Medit ClinicCADMedit ClinicCAD2024-06-21
08800026700159Medit DesignMedit Design2023-08-02
08800026700166Medit OrthoSimulationMedit OrthoSimulation2023-08-02
08800026700173Medit SplintsMedit Splints2023-08-02
08800026700180Medit TemporariesMedit Temporaries2023-08-02
08800026700289i900MO1-i900 2024-04-09
08800026700296Handpiece CoverMO1-HC12024-04-09
08800026700326 Calibration Tool MO1-CT12024-04-09
08800026700340Desktop CradleMO1-DC12024-04-09
08800026700357Wall Mount HolderMO1-WH12024-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
G775EVOLVE4140EVOLVESmaart Medical Systems, Inc.LLZ2026-07-09
080563044562053mensio WorkstationPie Medical Imaging B.V.LLZ2026-07-08
00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977583TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977590TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00889024699762ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699793ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699809ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699816ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699823ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00860012615308Denti.AI Auto-ChartDenti.AI Technology IncLLZ2026-06-24
00860012615315Denti.AI DetectDenti.AI Technology IncLLZ2026-06-24
00850631008872Roentgen WorksBrit Systems, LLCLLZ2026-06-23
00628184004500Intellijoint VIEWIntellijoint Surgical IncLLZ2026-06-09
00860005144082Brain AgeDeephealth, Inc.LLZ2026-06-08
07649997938038Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
07649997938052Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLLZ2026-06-05