DS Core Diagnosis

{0} FDA U.S. FOOD & DRUG ADMINISTRATION August 12, 2025 Dentsply Sirona Inc. % Deepthi Paknikar Senior Manager, Regulatory Affairs 221 West Philadelphia St. Suite 60W YORK, PA 17401 Re: K250755 Trade/Device Name: DS Core Diagnosis Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: July 9, 2025 Received: July 9, 2025 Dear Deepthi Paknikar: 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K250755 - Deepthi Paknikar Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K250755 - Deepthi Paknikar Page 3 assistance/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,  Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K250755 | | | Device Name DS Core Diagnosis | | | Indications for Use (Describe) DS Core Diagnosis is a software product for use in dentistry for viewing and interacting with digital or digitized patient media as well as supporting the diagnosis of digital and digitized patient media. Intended users will be able to view and analyze different media types in one viewer. The Panoramic Curve Proposal feature is intended for patients aged 12 years and older with permanent dentition. | | | 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) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} K250755_510k Summary # 510k Summary for DS Core Diagnosis-K250755 Prepared: 8/11/2025 ## Contact Details - Applicant Name: Dentsply Sirona Inc. - Applicant Address: 221 West Philadelphia St. Suite 60W York PA 17401 United States - Applicant Contact Telephone: 630-201-1612 - Applicant Contact: Dr. Deepthi Paknikar - Applicant Contact Email: deepthi.paknikar@dentsplysirona.com ## Device Name - Device Trade Name: DS Core Diagnosis - Common Name: System, Image Processing, Radiological - Classification Name: Medical image management and processing system - Regulation Number: 892.2050 - Product Code(s): QIH ## Legally Marketed Predicate Devices - Predicate K#: K132773 - Predicate Trade Name: Sidexis 4 - Product Code: LLZ ## Device Description Summary DS Core Diagnosis is a cloud-based dental imaging software that provides access to dental media and images via an active internet connection. It is a medical device that can only be used in combination with the DS Core Platform. Classified as a Class II dental imaging software, DS Core Diagnosis allows users to view a variety of media types, including 2D and 3D images (e.g., bitewings, periapicals, panoramic, CBCT, etc.), as well as photos and documentation. The software includes standard image viewing tools such as annotation, flip, rotate, contrast adjustment, brightness, and magnification. DS Core Diagnosis also features a Machine Learning enabled panoramic curve proposal algorithm for a proposed panoramic curve of a CBCT scan along the dental arch, which can be adjusted and reviewed by the user. The architecture is a Convolutional Neural Network (CNN) model. DS Core Diagnosis does not interact directly with patients or control any life-sustaining devices. The software does not perform diagnoses; instead, it provides tools to assist qualified clinicians in interpreting the displayed images and making informed decisions. ## Intended Use/Indications for Use DS Core Diagnosis is a software product for use in dentistry for viewing and interacting with digital or digitized patient media as well as supporting the diagnosis of digital or digitized patient media. Intended users will be able to view and analyze different media types in one viewer. The Panoramic Curve Proposal feature is intended for patients aged 12 years and older with permanent dentition. Page 1 of 3 {5} K250755_510k Summary ## Indications for Use Comparison Both the subject and predicate devices share the same essential indications for use. While there are minor distinctions—such as the subject device's absence of image acquisition and its cloud-based functionality—these differences do not affect the safety and effectiveness of the device. Both devices ultimately serve the same core purpose: to provide a platform for image review and diagnosis by qualified professionals. ## Technological Comparison Both devices are software as a medical device and allow users to view a variety of media types, including 2D and 3D images. The subject device is a cloud-based software as a medical device, whereas the predicate device is a downloaded desktop-based software as a medical device. The subject device does not include image acquisition, whereas the predicate device does. Both devices offer the same fundamental user-defined settings for image viewing, such as brightness, contrast, zoom, gamma, moving content in the media window, and image navigation. Minor differences in the viewer exist, such as the organization of the viewing windows or the appearance of feature (brightness, contrast, etc.) icons. Both devices include a panoramic curve proposal feature that can be manually reviewed and adjusted by the user. The panoramic curve proposal feature is AI/ML enabled in the subject device and is not AI/ML enabled for the predicate device. ## Non-Clinical Tests Summary & Conclusions Nonclinical performance testing results were reviewed as part of this submission. Software verification and validation testing was also completed. For model-specific performance evaluation, the panoramic curve proposal success rate (PCPSR) was measured. The PCPSR represents the percentage of cases where the proposed panoramic curve projection layer includes all teeth in the scan. The evaluation results showed that the panoramic curve proposal performance met the prespecified acceptance criteria. Dentsply Sirona Scans: PCPSR of 98.81%, with the lower bound of the 95% CI at 94.57%. All Scans (Dentsply Sirona & Third Party): PCPSR of 99%, with 99 of 100 scans considered "successful" and the lower bound of the 95% CI at 95.42%. Various subgroups were analyzed, yielding a PCPSR range of 97.78-100%, all passing the acceptance criteria. An expert clinical evaluation was also conducted that passed all predefined acceptance criteria. In this evaluation, clinical experts assessed a dataset made up of CBCT images, to evaluate the reconstructed CBCT panorama to determine the clinical acceptability of the default panoramic image (without user modification) with the panoramic curve proposal generated by the Panoramic Curve Proposal (PCP) algorithm. The results demonstrated that the predefined primary endpoint acceptance criteria were met, which was to determine the acceptability (pass/fail) of the CBCT reconstructed panoramic images based on the panoramic curve proposal (without user modification) to begin working per the standard of care. The results reported a 92.5% pass rate overall for the primary endpoint of this evaluation, demonstrating that the expert clinical evaluation was successful for the panoramic curve proposal algorithm. Page 2 of 3 {6} K250755_510k Summary System validation and usability testing for the DS Core Diagnosis device were conducted with clinicians, including the panoramic curve proposal feature in the scope. The results demonstrated that all tests were successfully passed. In summary, the panoramic curve proposal feature performance met the prespecified acceptance criteria, with a very high success rate and highly generalizable performance across different subgroups. Regardless of this strong performance, the users of the device retain full autonomy and can adjust and review the proposed panoramic curve. The results of nonclinical performance testing support the determination of substantial equivalence. Page 3 of 3