DTX Studio Clinic is a software program for the acquisition, management, transfer and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental restorative solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.

Device Description

DTX Studio Clinic is a software interface for dental/medical practitioners used to analyze 2D and 3D imaging data, in a timely fashion, for the treatment of dental, cramomaxillofacial and related conditions. DTX Studio Clinic displays and processes imaging data from different devices (i.e. intraoral X-Rays, (CB)CT scanners, intraoral scanners, intraoral and extraoral cameras).

AI/ML Overview

This document is a 510(k) Premarket Notification for the DTX Studio Clinic 3.0. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed technical study report with specific acceptance criteria and performance metrics for novel functionalities.

Therefore, the requested information regarding detailed acceptance criteria, specific performance data (e.g., accuracy metrics), sample sizes for test sets, data provenance, expert qualifications, and ground truth establishment for the automatic annotation of mandibular canals is not explicitly detailed in the provided text.

The document states that "Automatic annotation of the mandibular canals" is a new feature in DTX Studio Clinic 3.0, and it is compared to the reference device InVivoDental (K123519) which has "Creation and visualization of the nerve manually or by using the Automatic Nerve feature." However, it does not provide the specific study details for validating this new feature within DTX Studio Clinic 3.0. It only broadly states that "Software verification and validation testing was conducted on the subject device."

Based on the provided text, I cannot fulfill most of the requested information directly because it is not present. The document's purpose is to establish substantial equivalence based on the overall device function and safety, not to detail the rigorous validation of a specific AI/ML component with numerical acceptance criteria.

However, I can extract the available information and highlight what is missing.

Acceptance Criteria and Study for DTX Studio Clinic 3.0's Automatic Mandibular Canal Annotation (Information extracted from the document):

Given the provided text, the specific, quantitative acceptance criteria and detailed study proving the device meets these criteria for the automatic annotation of the mandibular canal are not explicitly described. The document focuses on a broader claim of substantial equivalence and general software validation.

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Metric	Acceptance Criteria	Reported Device Performance	Source/Methodology (if available in text)
Automatic annotation of mandibular canals	Not explicitly stated in quantitative terms. Implied acceptance is that the functionality is "similar as in the reference device InVivoDental (K123519)" and the user can "manually indicate or adjust the mandibular canal."	No specific performance metrics (e.g., accuracy, precision, recall, Dice coefficient) are provided. The text states: "The software automatically segments the mandibular canal based on the identification of the mandibular foramen and the mental foramen. This functionality is similar as in the reference device InVivoDental (K123519). The user can also manually indicate or adjust the mandibular canal."	Comparison to reference device and user adjustability. Software verification and validation testing was conducted, but details are not provided.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for the automatic mandibular canal annotation feature. The document states "Software verification and validation testing was conducted on the subject device," but provides no numbers.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication Method: Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: Not mentioned or detailed. The document primarily makes a substantial equivalence claim based on the device's overall functionality and features, not a comparative effectiveness study involving human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Not explicitly detailed. The document describes the automatic segmentation functionality and mentions that the user can manually adjust, implying a human-in-the-loop scenario. No standalone performance metrics are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: Not specified for the automatic mandibular canal annotation. Given the context of a dental/maxillofacial imaging device, it would likely involve expert annotations on CBCT scans, but this is not confirmed in the text.

8. The sample size for the training set:

Training Set Sample Size: Not specified. This document is a 510(k) submission, which focuses on validation, not the development or training process.

9. How the ground truth for the training set was established:

Ground Truth Establishment for Training Set: Not specified.

Summary of what can be inferred/not inferred from the document regarding the mandibular canal annotation:

New Feature: Automatic annotation of mandibular canals is a new feature in DTX Studio Clinic 3.0 that was not present in the primary predicate (DTX Studio Clinic 2.0).
Comparison to Reference Device: This new feature's "functionality is similar as in the reference device InVivoDental (K123519)", which has "Creation and visualization of the nerve manually or by using the Automatic Nerve feature."
Human Oversight: The user has the ability to "manually indicate or adjust the mandibular canal," suggesting that the automatic annotation is an aid to the diagnostic process, not a definitive, unreviewable output. This is typical for AI/ML features in medical imaging devices that are intended to support, not replace, clinical judgment.
Validation Claim: The submission states that "Software verification and validation testing was conducted on the subject device and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'." This implies that the validation was performed in accordance with regulatory guidelines, but the specific details of that validation for this particular feature are not disclosed in this public summary.

Summary

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March 25, 2022

Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the U.S. Food & Drug Administration logo, with the FDA acronym in a blue square.

Nobel Biocare AB % Wim Vrydag QA/RA Manager Nobel Biocare c/o Medicim NV Stationsstraat 102 Mechelen, 2800 BELGIUM

Re: K213562

Trade/Device Name: DTX Studio Clinic 3.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: February 18, 2022 Received: February 22, 2022

Dear Wim Vrydag:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

, for

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213562

Device Name DTX Studio Clinic 3.0

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/2 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter N on the left, followed by the words "Nobel Biocare" in black font on the right. The word "Nobel" is on the top line, and the word "Biocare" is on the bottom line with a trademark symbol.

1. 510(k) Summary

I. Submitter

Submitted by: Nobel Biocare c/o Medicim NV Stationsstraat 102 Mechelen, 2800, Belgium Establishment Registration No. 3005739655 Telephone: +32 15 44 32 00 Facsimile: +32 15 44 32 09 Email: wim.vrydag@envistaco.com

Submitted for: Nobel Biocare AB Vastra Hamngatan 1 Göteborg, SE-411 17, Sweden Establishment Registration No. 9611992 Date Prepared: January 18, 2022

II. Device

Name of Device: DTX Studio Clinic 3.0 Manufacturer: Nobel Biocare AB Common or Usual Name: Medical Image Management and Processing System Classification Name: System, Image Processing, Radiological CFR Number: 892.2050 Regulatory Class: II Product Code: LLZ

III. Predicate Device

Substantial equivalence is claimed to the following devices: Primary Predicate: Predicate Device: DTX Studio Clinic Predicate 510(k): K203156 Company: Nobel Biocare AB Common or Usual Name: Medical Image Management and Processing System Classification Name: System, Image Processing, Radiological CFR Number: 892.2050 Regulatory Class: II Product Code: LLZ

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DTX Studio Clinic 3.0 K213562

Image /page/4/Picture/2 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter N on the left, followed by the words "Nobel Biocare" in black font on the right. The letters are sans-serif and the TM symbol is present after the word Biocare.

Reference device:

Reference Device: InvivoDental Reference 510(k): K123519 Company: Anatomage Inc. Common or Usual Name: Medical Image Management and Processing System Classification Name: System, Image Processing, Radiological CFR Number: 892.2050 Regulatory Class: II Product Code: LLZ

IV. Device Description

V. Indications for Use

VI. Comparison of Technological Characteristics

The subject and predicate device are software-based data visualization tools which allow for transfer of medical images and enhancement with intention to support diagnostic process and treatment planning of craniomaxillofacial patients.

Summary comparison of technological similarities and differences

The subject device DTX Studio Clinic 3.0 and the predicate device DTX Studio Clinic 2.0 share following characteristics:

Clinical Use - intended to support the diagnostic and treatment planning process of craniomaxillofacial anatomical area
Clinical image data import and acquisition from supported devices, data visualization, ● distance and angular measurements

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Image /page/5/Picture/2 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter N on the left and the words "Nobel Biocare" on the right. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".

Image enhancement image filter application, annotations .
. Airway volume segmentation
Intraoral radiograph (IOR) automatic image sorting to an FMX template ●
Dental implant planning
. Patient data management features

DTX Studio Clinic 3.0 is different from the predicate device DTX Studio Clinic 2.0 as follows:

. Automatic annotation of the dental mandibular canal
Importing Face scan
Removal Intra oral scanner module (NOF) .

A comparison of the subject and predicate devices is provided in the table below.

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Image /page/6/Picture/2 description: The image contains the logo for Nobel Biocare. On the left side of the logo is a red symbol that looks like the letter N. To the right of the symbol is the text "Nobel Biocare" in black font. The word "Nobel" is on the top line, and the word "Biocare" is on the bottom line.

Table 1: Comparison of DTX Studio Clinic to Predicate Devices

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DTX Studio Clinic 3.0

Image /page/7/Picture/2 description: The image shows the logo for Nobel Biocare. The logo consists of a stylized red letter N on the left, followed by the words "Nobel Biocare" in black text on the right. The word "Nobel" is on the top line, and the word "Biocare" is on the bottom line with a trademark symbol.

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DTX Studio Clinic 3.0 K213562

Image /page/8/Picture/2 description: The image contains the logo for Nobel Biocare. On the left is a red symbol that looks like the letter N. To the right of the symbol is the text "Nobel Biocare" in a simple, sans-serif font. The word "Nobel" is on top of the word "Biocare", and there is a trademark symbol after the word "Biocare".

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DTX Studio Clinic 3.0 K213562

Image /page/9/Picture/2 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter N on the left and the words "Nobel Biocare" on the right. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".

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DTX Studio Clinic 3.0 K213562

Image /page/10/Picture/2 description: The image shows the logo for Nobel Biocare. The logo consists of a red letter N on the left side and the words "Nobel Biocare" on the right side. The letter N is stylized and appears to be made up of two intersecting lines.

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Discussion

Similarities:

The subject device DTX Studio Clinic 3.0 and primary predicate device DTX Studio Clinic 2.0 (K203156) have the same Intended Use and share most software functions/features. Automatic annotation of the mandibular canals is shared with the reference device InVivoDental (K123519).

As seen in the table above, the subject and predicate devices are equivalent in terms of software functionalities. All devices allow import of variety of 2D/3D imaging data, its enhancement, viewing, processing and visualization for the purpose of supporting the diagnostic and treatment planning process.

Difference in indications for use and software features are discussed below.

Differences:

Indications for Use

The Indications for Use statement between the subject and the primary predicate device (K203156) are the same.

Both DTX Studio Clinic 3.0 and the primary predicate device DTX Studio Clinic 2.0 allow display and enhancement of medical images from various sources, i.e. from various digital imaging systems. In addition, they also allow for retrieving and storage of image data within the system (locally) or across computer systems in distributed locations. DTX Studio Clinic 3.0 allows transfer of images and patient data (store and retrieval) to and from the DTX Studio Core database, thus making the data available in different locations.

Both the subject and primary predicate are software solutions indicated for the display and processing of medical image information and are intended to support the diagnostic process predominately within dentistry. Oral and maxillofacial surgeons offer treatments which can cover the complete craniomaxillofacial area (including the dental area). For this reason, the subject device allows the user to visualize and evaluate data for the entire craniomaxillofacial area, as a support for the diagnostic process.

Both the subject and primary predicate provide design input for restorative solutions to 3rd party software or software from DTX Studio ecosystem, but it does not provide functionality of designing restorations within the software itself.

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Differences in software features/functionality

Input data/Image acquisition - 3D Face scans - The difference between the subject device and the predicate device is that 3D facial scans can now be imported and visualized in the software. 3D Face scans can be used to provide the user with additional information to perform diagnosis and treatment planning.

Diagnostic -Automatic annotation of the mandibular canals - The difference between the subject device and the predicate device is that DTX Studio Clinic 3.0 allows the segmentation and visualization of the mandibular canals. The software automatically segments the mandibular canal based on the identification of the mandibular foramen and the mental foramen. This functionality is similar as in the reference device InVivoDental (K123519). The user can also manually indicate or adjust the mandibular canal.

Intraoral scanner- The difference between the subject device and the predicate device is that the DTX Studio ioscan module, classified as NOF, 872.3661 (510k exempt) is no longer available into the DTX Studio Clinic 3.0. This change does not affect the intended use of the software, since customers can import data from optical intraoral scanners into DTX Studio Clinic 3.0

Minor differences:

Various operating systems are currently supported by DTX Studio Clinic 3.0, due to release of new versions of these operating systems during the lifecycle of DTX Studio Clinic 3.0. DTX Studio Clinic 3.0 was tested and validated on these operating systems

VII. Performance Data

DTX Studio Clinic 3.0 is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485:2016 Standards. This device is in conformance with the applicable parts of IEC 62304:2006 standards. Design Control Activities, including risk management following the ISO 14971:2019, verification/validation testing, were conducted and are included in this submission.

The performance of the subject device was verified and validated following the guidance provided in FDA Guidance General Principles of Software Validation. This documentation includes testing which demonstrates that the requirements for the features have been met. Software documentation for Moderate Level of Concern and description of respective V&V activities, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, is also included as part of this submission.

Software Validation

Software verification and validation testing was conducted on the subject device and documentation was provided as recommended by FDA's Guidance for Industry and FDA

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Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

VIII. Conclusion

Based on the comparison of the intended use, the features and workflows, the user interface, the technical characteristics, and based on the software verification/validation activities described in this submission, DTX Studio Clinic 3.0 is found to be substantially equivalent to the identified Predicate Device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Criteria	DTX Studio Clinic 3.0 (subjectdevice)	DTX Studio Clinic 2.0 (Primarypredicate device)K203156	InVivoDental (reference devicefor automatic annotation ofmandibular canal)K123519	Comments
Indications forUse Statement	DTX Studio Clinic is a softwareprogram for the acquisition,management, transfer and analysisof dental and craniomaxillofacialimage information, and can be usedto provide design input for dentalrestorative solutions. It displays andenhances digital images fromvarious sources to support thediagnostic process and treatmentplanning. It stores and providesthese images within the system oracross computer systems at differentlocations.	DTX Studio Clinic is a softwareprogram for the acquisition,management, transfer and analysisof dental and craniomaxillofacialimage information, and can be usedto provide design input for dentalrestorative solutions. It displays andenhances digital images fromvarious sources to support thediagnostic process and treatmentplanning. It stores and providesthese images within the system oracross computer systems at differentlocations.	InVivoDental is a softwareapplication used for the display and3D visualization of medical imagefiles from scanning devices, such asCT, MRI, or 3D Ultrasound. It isintended for use by radiologists,clinicians, referring physicians andother qualified individuals toretrieve, process, render, review,store, print, assist in diagnosis, anddis tribute images utilizing standardPC hardware. Additionally,InVivoDental is a preoperativesoftware application used for thesimulation and evaluation of dentalimplants, orthodontic planning andsurgical treatments	Same
Classificationcode	LLZ	LLZ, NOF	LLZ
Inputdata/Imageacquisition	DICOM image data volumes, 2Dand 3D images such as (CB)CTscans and 2D images such asOPG/panorex images, acquisition ofX-Ray images from intra-oralsensors, cephalometric images,intra-oral images, clinical picturesand face scans	DICOM image data volumes, 2Dand 3D images such as (CB)CTscans and 2D images such asOPG/panorex images, acquisition ofX-Ray images from intra-oralsensors, cephalometric images,intra-oral images and clinicalpictures.	2D and 3D images such as CT andMRI, optical scans STL or PLY andprosthetic designsof restorations, photos.Image Capture and ExportAVI (Movie) Capture and ExportImport from PACS	Different – Seediscussion below
	STL, NXA, PLY files from intraoraland optical scanner.	STL, NXA, PLY files from intraoraland optical scanner.
Output data	Data is stored locally or in remotelyaccessible database in the network(DTX Studio Core).2D and 3D image export (DICOMimage data volumes, 2D and 3Dimages such as (CB)CT scans and2D images such as OPG/panoreximages, acquisition of X-Rayimages from intra-oral sensors,cephalometric images, intra-oralimages and clinical pictures.), STL,PLY, NXA file export.Export implant or restorativetreatment planDiagnostic findings report export.	Data is stored locally or in remotelyaccessible database in the network(DTX Studio Core).2D and 3D image export (DICOMimage data volumes, 2D and 3Dimages such as (CB)CT scans and2D images such as OPG/panoreximages, acquisition of X-Rayimages from intra-oral sensors,cephalometric images, intra-oralimages and clinical pictures.), STL,PLY, NXA file export.Export implant or restorativetreatment planDiagnostic findings report export.	Data is stored locally.2D and 3D image export (DICOMimage data volumes, 2D and 3Dimages such as (CB)CT scans and2D images such asOPG/panorex images, acquisition ofX-Ray images from intra-oralsensors, cephalometricimages, intra-oral images andclinical pictures.), STL, PLY,NXA file export.)Export data inDICOM/DICOMDIR format orproprietary format, includingtreatment plans with implants andmeasurements, traced nervesor other annotations, imagescaptured, sculpting operations,imported models, ortho tracingsfrom 3D analysis.Export optionally with aproprietary viewer or with webbrowser-based 3D viewer.Export to PACS	Same
Imageprocessing	Enhancement (image filterapplication), annotations,measurements (distance andangular, volume and surface areafor data segmentation),import/export.Airway volume segmentation.	Enhancement (image filterapplication), annotations,measurements (distance andangular, volume and surface areafor data segmentation),import/export.Airway volume segmentation.	Enhancement (image filterapplication), annotations, Linear,Angular, Circumferential, Area, andVolumetric Measurements (distanceand angular, volume and surfacearea for datasegmentation), bone density evaluation, import/export.Creation of fly-through /presentation movies in AVI format.	Same
	Alignment of surface scans, such asintra-oral or dental cast scans.STL/.PLY files with (CB)CT datafor accurate implant planning	Alignment of surface scans, such asintra-oral or dental cast scans.STL/.PLY files with (CB)CT datafor accurate implant planning	Airway volume segmentation.Endo visualizations.TMJ visualizations.Automatic Superimposition andMirroringAlignment of surface scans, such asintra-oral or dental cast scans.STL/.PLY files with (CB)CT datafor accurate implant planning.
SoftwareFeatures	Scan data:	Scan data:	Scan data:	Same
	The software can directly acquireimages from supported imagingmodalities or allow manual importof images by import dialog. Thedata can be manually adjusted withthe wizard editor.The data can be also imported from3rd party patient managementsystems via standard protocol -VDDS, or via Nobel Biocareproprietary OPP protocol.	The software can directly acquireimages from supported imagingmodalities or allow manual importof images by import dialog. Thedata can be manually adjusted withthe wizard editor.The data can be also imported from3rd party patient managementsystems via standard protocol -VDDS, or via Nobel Biocareproprietary OPP protocol	The software can open DICOM3D images from various devicetypes and producers by importdialog. The data can be manuallyadjusted with the wizard editor.Scan can be reoriented in 3Dcoordinates.Stitching of 3D volumes
	Diagnostic:The diagnostic module allows toreview and diagnose 2D and 3Dimage data as well as clinicalimages. The user can apply imagefilters and can measure length,angles and HU units.The software allows to compare 3Dimages and 2D intraoral images inthe same workspace	Diagnostic:The diagnostic module allows toreview and diagnose 2D and 3Dimage data as well as clinicalimages. The user can apply imagefilters and can measure length,angles and HU units.The software allows to compare 3Dimages and 2D intraoral images inthe same workspace	Diagnostic:The software allows to review 2Dand 3D image data. The user canapply image filters, modifybrightness and contrast.The user can apply image filters andcan measure length, angles, HUunitsvolumetric measurements of renderComparison of multiple 3D	Different - Seediscussion below
Visualization of airways, volumesegmentation, volume measurementand maximum constriction pointdetermination.Automatic annotation of themandibular canals based onanatomical landmarks	Visualization of airways, volumesegmentation, volume measurementand maximum constriction pointdetermination.	Visualization of airways, volumesegmentation, volume measurementand maximum constriction pointdetermination.Creation and visualization of thenerve manually or by using theAutomatic Nerve feature
Intraoral scanner:Import of surface scan files andtheir registration with other scans.	Intraoral scanner:DTX Studio ioscan module is a userinterface supporting a dental opticalimpression system, morespecifically an intraoral scanningdevice.Review of STL, PLY, NXA typedata within dedicated workspace	Intraoral scanner:Import of surface scan files andtheir registration with other scans.	Different - Seediscussion below
Automatic sorting algorithm:Intraoral radiograph (IOR)automatic image sorting to an FMXtemplate (dental X-ray imagelayout).	Automatic sorting algorithm:Intraoral radiograph (IOR)automatic image sorting to an FMXtemplate (dental X-ray imagelayout).	N/A	Same
Implant Planning:Functionality for implant planningtreatment. Adding dental implantshapes to DICOM data for treatmentplanning.	Implant Planning:Functionality for implant planningtreatment. Adding dental implantshapes to DICOM data for treatmentplanning.	Implant Planning:Functionality for implant planningtreatment. Adding dental implantshapes to DICOM data for treatmentplanning.Density profile controlAbutment planning and marginplanningBone graft simulation	Same
	Virtual tooth setup:	Virtual tooth setup:	Virtual tooth setup:	Same
	Algorithm calculates and visualizesa 3D tooth shape for a missing toothposition, based on a set of indicatedlandmarks and the loaded intra-oralscan	Algorithm calculates and visualizesa 3D tooth shape for a missing toothposition, based on a set of indicatedlandmarks and the loaded intra-oralscan	Library of wax-up and prostheticrestorations for crown-downplanningMesh editing and collisiondetecting featuresArticulation
Operatingsystemrequirements	Windows 10 64-bit, macOSCatalina, macOS BigSur	Windows 10 64-bitmacOS Mojave, macOS Catalina	Windows 7 64-bit, Windows 8 64-bit or Windows 10 64-bit., AppleBootcamp with Windows, macOSYosemite and higher	Different - Seediscussion below
Recommendedhardwarerequirements	CPU: quad-core of 2.8 GHz or more(such as Intel Core i5 or i7)RAM: 8GBGraphics card with support ofOpenGL 3.3 and 2GB memory ormore (4GB or more for 4Kdisplays)HDD: 10GB of free spaceMonitor: FullHD (1920x1080) orhigher	CPU: quad-core of 2.8 GHz or more(such as Intel Core i5 or i7)RAM: 8GBGraphics card with support ofOpenGL 3.3 and 2GB memory ormore (4GB or more for 4Kdisplays)HDD: 10GB of free spaceMonitor: FullHD (1920x1080) orhigher	CPU: Intel Core i5 2400,recommended Intel Core i7 4000 orsimilar. RAM min 4GB,recommended 8GB. Graphiccard Intel HD 4000, recommendedAMD Radeon RX 580 orcomparable.HDD: 100 GB minimum, 500GB recommended.	Same