FDA.reportPublic FDA data

CS MODEL+

Primary DI
00693856000302
Brand
CS MODEL+
Company
Dental Imaging Technologies Corporation
Model
594483
Catalog number
594483
Device description
LICENCE CS MODEL+ V5 ALIGNER CAPABILITY
Published
2023-12-13
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
PNNOrthodontic Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNNOrthodontic SoftwareDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193390000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193390000CS Model+Trophy2020-04-02PNN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00693856000302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00693856000302006938560003026938560003020693856000302

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
800111106
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D090101397120IXS S2 Kit, CT, US, FR-CA1.013.97122026-05-12
00693856000203Assembly-IS 3700 SIDE TIPIS 3700TA08502025-12-04
00693856000227Assembly-IS 3700 POSTERIOR TIPIS 3700TA08602025-12-04
D090101329460DEXIS IXS Size 1 Sensor - R1.013.29461.013.29462026-04-01
D090101329470DEXIS IXS Size 2 Sensor - R1.013.29471.013.29472026-04-01
D090800045720DEXIS Ti2 Sensor - R - S8.000.45728.000.45722026-04-01
D090800045730DEXIS IXS Size 1 Sensor - S8.000.45738.000.45732026-04-01
D090800045740DEXIS IXS Size 1 Sensor - R - S8.000.45748.000.45742026-04-01
D090800045750DEXIS IXS Size 2 Sensor - S8.000.45758.000.45752026-04-01
D090800045760DEXIS IXS Size 2 Sensor - R - S8.000.45768.000.45762026-04-01
D090800045770DEXIS Ti2 Kit - S8.000.45778.000.45772026-04-01
D090800045780DEXIS IXS Size 2 Sensor - D8.000.49788.000.49782026-04-01
D090800045790DEXIS IXS S1 Kit8.000.45798.000.45792026-04-01
D090800045810DEXIS IXS S2 Kit8.000.45818.000.45812026-04-01
D090800045830DEXIS Ti2 Kit - S8.000.45838.000.45832026-04-01
D090800045840DEXIS Ti2 Kit - R - S8.000.45848.000.45842026-04-01
D090800045850IXS S1 Warranty Replacement - S8.000.45858.000.45852026-04-01
D090800045860IXS S1 Warranty Replacement Kit8.000.45868.000.45862026-04-01
D090800045870IXS S2 Warranty NEW Kit8.000.45878.000.45872026-04-01
D090800045880IXS S2 Warranty Replacement Kit8.000.45888.000.45882026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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