Primescan 2 can be used as a diagnostic aid by licensed dentists for detection of caries on visible tooth surfaces, proximal caries, and tooth cracks.

Device Description

The Primescan 2 is an intraoral scanner that records and generates digital images to provide caries diagnosis support using additional light sources at 405 nm and 850 nm and an optical filter to filter out the excitation light. By illuminating the tooth with these two wavelengths, two diagnosis support modes are realized, the fluorescence mode and the near-infrared mode. The acquired 2D data from the scanner can be viewed in the software in a live stream video during acquisition. The images are also stored in the cloud platform software for later patient communication.

In fluorescence mode, the tooth (or teeth) are illuminated with UV light (405 nm). This stimulates an autofluorescence of the enamel in the green wavelength range. In addition, the red fluorescence is stimulated in carious areas on the teeth. All stimulated fluorescence responses are significantly weaker in terms of their light intensity compared to the back-reflected excitation light. For this reason, the excitation light is filtered out with the aid of an optical filter. The dental professional can use the 2D image data of the fluorescence response (live stream video) as additional information for caries diagnosis.

For near-infrared mode (NIR mode), the tooth or teeth are illuminated with 850 nm. Enamel is partially transparent in this wavelength. The illumination can therefore penetrate the tooth and is reflected by structural defects such as cracks and cavities, as well as from the dentin core. The reflected light is picked up by the 2D sensor of the scanner.

When used, a sleeve is placed over the distal end of the scanner. This sleeve is the only patient contacting component and is offered as either a single-use disposable or a multi-use sleeve that is reprocessed.

AI/ML Overview

Here's the breakdown of the acceptance criteria and study information for the Primescan 2 device, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

The provided document does not explicitly state quantitative acceptance criteria or a specific table outlining them. However, it does mention that "in vivo bench tests demonstrated that Primescan-2 is effective as a diagnostic aid for occlusal caries using the fluorescence function and tooth cracks using the NIR function." This implies that the device met an unstated level of effectiveness for these diagnostic aids.

Since specific quantitative metrics (e.g., sensitivity, specificity, accuracy) are not provided in the summary, we cannot populate a detailed table with numerical acceptance criteria and performance outcomes.

Acceptance Criterion	Reported Device Performance
Effectiveness as diagnostic aid for occlusal caries (fluorescence mode)	Demonstrated effectiveness
Effectiveness as diagnostic aid for tooth cracks (NIR mode)	Demonstrated effectiveness

Study Details

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

Sample Size for Test Set: Not specified in the provided document.
Data Provenance: The study was "in vivo bench tests," implying data was collected from living subjects. The country of origin and whether it was retrospective or prospective is not explicitly stated.

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 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 in the provided document. The study described is "Performance Validation Testing of the Caries diagnostic Aid - In vivo bench tests demonstrated that Primescan-2 is effective as a diagnostic aid..." This describes standalone device performance rather than human-in-the-loop improvement.

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

Standalone Performance Study: Yes, a standalone performance study was done. The document states: "Performance Validation Testing of the Caries diagnostic Aid - In vivo bench tests demonstrated that Primescan-2 is effective as a diagnostic aid for occlusal caries using the fluorescence function and tooth cracks using the NIR function." This indicates the device's ability to provide a diagnostic aid on its own.

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

Type of Ground Truth: Not explicitly stated. For "in vivo bench tests" related to caries and tooth cracks, ground truth would typically be established through a combination of visual-tactile examination by experienced clinicians, potentially supplemented by radiography or even histology (though less common for a diagnostic aid). However, the document does not specify the method used here.

8. The sample size for the training set

Sample Size for Training Set: Not applicable or not specified. This device appears to be a direct imaging and diagnostic aid rather than an AI/ML algorithm that requires a separate training set. The "diagnostic support" refers to the illumination and optical filtering techniques, not necessarily an AI algorithm trained on a dataset.

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

Ground Truth for Training Set: Not applicable, as there's no indication of an AI/ML algorithm with a training set. The device operates on optical principles.

Key Observations and Limitations of Information:

The provided 510(k) summary focuses highly on technological comparisons, safety, and regulatory compliance (electrical safety, biocompatibility, reprocessing, software, cybersecurity).
While it mentions "Performance Validation Testing," it lacks specific quantitative results (e.g., sensitivity, specificity, accuracy, AUC) that are typically associated with diagnostic device clearances.
The clinical study details, such as sample size, expert qualifications, and ground truth establishment methods for the performance validation, are not provided in this specific document. This information would typically be in a more detailed study report submitted to the FDA, but is summarized very broadly here.
The device is described as providing "diagnostic support" using optical modes (fluorescence and NIR), rather than an explicit AI algorithm.

Summary

FDA 510(k) Clearance Letter - Primescan 2

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 29, 2025

Dentsply Sirona Inc.
Diane Rutherford
Director Regulatory Affairs
221 West Philadelphia Street, Suite 60W
York, Pennsylvania 17401

Re: K250771
Trade/Device Name: Primescan 2
Regulation Number: 21 CFR 872.1745
Regulation Name: Laser Fluorescence Caries Detection Device
Regulatory Class: Class II
Product Code: NTK, NBL
Dated: March 14, 2025
Received: July 31, 2025

Dear Diane Rutherford:

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.

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"

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K250771 - Diane Rutherford Page 2

(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-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).

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K250771 - Diane Rutherford Page 3

Sincerely,

Bobak Shirmohammadi - S

For Michael E. Adjodha, M.ChE., RAC, CQIA
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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Food and Drug Administration
Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Submission Number (if known)
K250771

Device Name
Primescan 2

Indications for Use (Describe)
Primescan 2 can be used as a diagnostic aid by licensed dentists for detection of caries on visible tooth surfaces, proximal caries, and tooth cracks.

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.

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510(k) Summary

510(k) #: K250771
510(k) Summary Prepared on: 2025-08-29

Contact Details

21 CFR 807.92(a)(1)

Field	Value
Applicant Name	Dentsply Sirona Inc.
Applicant Address	221 West Philadelphia Street, Suite 60W York PA 17401 United States
Applicant Contact Telephone	704-458-1942
Applicant Contact	Ms. Diane Rutherford
Applicant Contact Email	diane.rutherford@dentsplysirona.com
Correspondent Name	Dentsply Sirona Inc.
Correspondent Address	221 West Philadelphia Street, Suite 60W York PA 17401 United States
Correspondent Contact Telephone	704-458-1942
Correspondent Contact	Ms. Diane Rutherford
Correspondent Contact Email	diane.rutherford@dentsplysirona.com

Device Name

21 CFR 807.92(a)(2)

Field	Value
Device Trade Name	Primescan 2
Common Name	Laser fluorescence caries detection device
Classification Name	Caries Detector, Laser Light, Transmission
Regulation Number	872.1745
Product Code(s)	NTK, NBL

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K182712	DEXIS CariVu 3-in-1	NTK, NBL

Device Description Summary

21 CFR 807.92(a)(4)

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response (live stream video) as additional information for caries diagnosis.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Primescan 2 can be used as a diagnostic aid by licensed dentists for detection of caries on visible tooth surfaces, proximal caries, and tooth cracks.

Indications for Use Comparison

21 CFR 807.92(a)(5)

The proposed Primescan 2 is intended for the same indications for use as the predicate device DEXIS CariVu 3-in-1 by KaVo (K182712) as a diagnostic aid for detection of dental caries and tooth cracks.

Technological Comparison

21 CFR 807.92(a)(6)

The proposed Primescan 2 functions in a manner similar to and is intended for the same indications for use as the predicate device DEXIS CariVu 3-in-1 by KaVo (K182712). Both the proposed and predicate devices share the technological characteristics of fluorescence mode, transillumination mode, and CMOS high sensor performance. Both share the principles of operation for fluorescence mode (405nm wavelength) for transillumination mode (850nm wavelength) for visualization of caries.

Some technological differences exist in resolution, focal length, and the patient contacting components. The patient contacting component of the Primescan 2 includes a disposable, single-use sleeve as well as a multi-use sleeve (requires reprocessing). The predicate uses a disposable sheath with a reusable tip (requiring sterilization). Another difference is the environment in which the software resides. Primescan 2 is a wireless device, operating with a battery and Wi-Fi connection, with software being cloud-native. The ability of the Primescan 2 to function in a completely wireless mode, the size, and power differs from that of the predicate. The software being located in the cloud does not impact the way the scanner performs or functions.

These differences do not raise new concerns of substantial equivalence. The comparison demonstrates substantial equivalence in terms of indications, technology, and performance, with the differences being demonstrated to not impact substantial equivalence. The performance testing demonstrates that the proposed Primescan 2 performs as well as the predicate device.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

Bench testing performed in support of this eSTAR submission for the Primescan 2 includes the following:

Performance Validation Testing of the Caries diagnostic Aid - In vivo bench tests demonstrated that Primescan-2 is effective as a diagnostic aid for occlusal caries using the fluorescence function and tooth cracks using the NIR function.
Photobiological Safety of the LEDs was assessed by an external laboratory in accordance with EN 62471 under worst-case conditions to confirm the safety of the lighting used in the Primescan 2.
Spatial Resolution Comparison to Predicate Device - Spatial resolution comparison testing was performed where Primescan 2 was compared to the predicate device DIAGNOcam.
Equivalence testing of Near InfraRed (NIR) and Fluorescence imaging modes for Multiuse sleeve and Single use sleeve - The Multiuse Sleeve and Single use sleeve were tested to be equivalent with respect to using of the near infrared (NIR) and fluorescence imaging modes of the Primescan 2.
Endurance Testing for Multiuse Sleeve - To demonstrate the reusability of the Multiuse the impact of attaching and detaching sleeves as well as the impact of repeated cleaning, and disinfection were tested.

Additionally, the following guidance and standards were used in the non-clinical testing:

Electrical Safety & EMC: FDA Guidance: "Electromagnetic Compatibility (EMC) of Medical Devices", IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - requirements and tests, IEC 60601-1-6 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Wireless Technology: FDA Guidance: "Radio Frequency Wireless Technology in Medical Devices- Guidance for Industry and FDA Staff", IEEE ANSI USEMCSC C63.27- American National Standard for Evaluation of Wireless Coexistence
Reprocessing: FDA Guidance: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", ISO 17664-1 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices, Part 1: Critical and semi-critical medical devices, AAMI TIR12 - Designing, testing, and labeling medical devices intended for

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processing by health care facilities: A guide for device manufacturers, AAMI ST98 - Cleaning validation of health care products - Requirements for development and validation of cleaning processes for medical devices

Biocompatibility: FDA Guidance: "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'", ISO 10993-1 - Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process, ISO 10993-10 - Biological evaluation of medical devices- Part 10: Tests for skin sensitization, ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, ISO 10993-23 - Biological evaluation of medical devise - Part 23: Tests for irritation
Software and Cybersecurity: FDA Guidance: "Content of Premarket Submissions for Device Software Functions", IEC 62304 - Medical device software - Software life cycle processes, FDA Guidance: "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions"

The conclusions demonstrate that the device is substantially equivalent.

Regulation Number and Section

§ 872.1745 Laser fluorescence caries detection device.

(a)
Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.(b)
Classification. Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.