(392 days)
C50 is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details invisible to the naked eye or with a mirror (thanks to magnification).
The C50 is an intraoral video camera equipped with LEDs to illuminate the inspection site. The C50 optics and its complementary metal oxide semiconductor (CMOS) sensor capture the natural fluorescence of the site under observation and convert the images into a video signal that is sent to the computer via a USB interface. The dental practitioner can use the images displayed on the computer screen as an aid in diagnosis. A USB Type-C (camera) to USB-A cable is provided to connect the C50 to a computer. The C50 provides the following functions: Aid in the detection of pit and fissure caries Information about patient dental hygiene Highlighting of dental plaque Highlighting of gingival inflammations (restricted to gingival inflammation that leads to bleeding upon probing) Showing the difference between "before" and "after" care (follow-up). In CARIO mode (blue mode), the camera assists the dental practitioner by highlighting potential carious areas in pits and fissures on the occlusal surface of the teeth. In DAYLIGHT mode (white mode), the camera enables visualization of anatomical details invisible to the naked eye or with a mirror (thanks to its magnification). DAYLIGHT+ mode (white mode) is a shortcut version of DAYLIGHT mode where the contrast has been pushed from 20 to 70. In PERIO mode (yellow mode), the camera helps the dental practitioner to visualize dental plaque, in addition to highlighting areas of gingival inflammation (restricted to gingival inflammation that leads to bleeding upon probing).
The C50 is an intraoral camera intended for use in general dentistry. Its indications for use include aid in the diagnosis of pit and fissure caries, highlighting dental plaque and gingival inflammations (restricted to those leading to bleeding upon probing), and functioning as an intra-oral camera for magnified visualization of anatomical details.
Here's the breakdown of acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes comparison testing and other verification and validation tests rather than specific quantitative acceptance criteria for clinical performance metrics (e.g., sensitivity, specificity for caries detection). Instead, the performance testing focuses on demonstrating substantial equivalence to the predicate device and compliance with relevant safety and technical standards.
| Acceptance Criteria Category | Specific Test/Performance Aspect | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Clinical Modes (CARIO, DAYLIGHT, PERIO) | Demonstrated to be identical to the predicate device. |
| New Mode (DAYLIGHT+) | Functions similarly to DAYLIGHT mode but offers higher contrast. | |
| Image Quality (sharpness, size, resolution, focus position) | Comparison testing showed substantial equivalence to the predicate device, even with the Full HD resolution enhancement of the C50. | |
| Safety and Performance | Temperature elevation in target tissue | Comparison testing showed substantial equivalence to the predicate device. |
| Mechanical performance of reprocessed C50TIPS (maintains position, blocks external light) | Testing ensured the device maintains its position and completely blocks external light. | |
| Fit of third-party protective sheath with C50 and C50TIPS | Mechanical testing confirmed appropriate fit. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| Electrical Safety (IEC 60601-1 and 60601-1-2) | Testing was conducted, and the device was found to be consistent with appropriate sections of the standards. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| EMC (IEC 60601-1-2, IEC/TR 60601-4-2) | Testing was conducted, and the device was found to be consistent with appropriate sections of the standards. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| Photobiological Safety (IEC 62471) | Testing was conducted, and the device was found to be consistent with the appropriate section of the standard. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| Software Validation (IEC 62304) | Validation was performed on the C50's firmware, consistent with the appropriate section of the standard. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| Reprocessing Validation (FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings") | Validation was conducted on the C50, C50TIPS, and USB cable in accordance with FDA guidance. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| Biocompatibility (ISO 10993-1, FDA Guidance Document "Use of International Standard ISO 10993-1") (C50TIPS) | Chemical characterization, cytotoxicity, and acute systemic toxicity tests were considered, and acceptance criteria were met for all. The patient contact materials are identical in formulation, manufacturing, processing, and geometry to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a test set in the traditional sense of a clinical diagnostic study with patient data used for accuracy evaluation. Instead, it refers to "comparison testing of image quality" and "mechanical performance testing" conducted on the device and its accessories (C50, C50TIPS, protective sheath, USB cable).
- Sample Size: Not specified in terms of number of patients or cases. The testing appears to have been performed on the devices themselves and associated accessories.
- Data Provenance: Not applicable in the context of device performance testing. The "data" generated comes from direct laboratory and safety testing of the device hardware and software. No patient or human subject data is mentioned for performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As described above, the testing performed was focused on device characteristics and substantial equivalence to a predicate, not on a diagnostic accuracy study requiring expert ground truth establishment for patient cases.
4. Adjudication Method for the Test Set
Not applicable, as no clinical diagnostic test set with multiple reader interpretations requiring adjudication is described.
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
No MRMC comparative effectiveness study is described. The C50 is an intraoral camera and not an AI-powered diagnostic algorithm that assists human readers in interpretation. It provides visual information to the dental practitioner.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The C50 is a hardware device (intraoral camera with different illumination modes) that provides visual information. It is not an algorithm, and therefore, a standalone algorithm performance study is not applicable. The device's "diagnosis aid" function relies on the visual information it provides to the human practitioner.
7. The Type of Ground Truth Used
The ground truth used for relevant testing was based on:
- Comparison to a predicate device (SOPROCARE): Many aspects of the C50's performance (image quality, temperature elevation, functional modes) were evaluated against the known performance of the predicate device to establish substantial equivalence.
- Compliance with established standards: Electrical safety, EMC, photobiological safety, software validation, reprocessing validation, and biocompatibility were evaluated against recognized international and FDA standards.
- Engineering specifications/functional requirements: Mechanical tests ensured specific physical functionalities like the fit of accessories and light blocking.
8. The Sample Size for the Training Set
Not applicable. The C50 is a medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
December 14, 2023
SOPRO Kim Rouahi Regulatory Affairs & Quality Director Zac Athelia IV Avenue Des Genevriers La Ciotat, Bouches-Du-Rhone 13705 FRANCE
Re: K223470
Trade/Device Name: C50 Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: Class II Product Code: NBL Dated: December 1, 2023 Received: December 1, 2023
Dear Kim Rouahi:
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.
{1}------------------------------------------------
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 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-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 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.
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-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).
{2}------------------------------------------------
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, 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
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K223470
Device Name C50
Indications for Use (Describe)
C50 is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details invisible to the naked eye or with a mirror (thanks to magnification).
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}------------------------------------------------
510(K) Summary - K223470
Date: December 11, 2023
| Submitter: | SOPRO |
|---|---|
| Name: | ZAC Athélia IV - Avenue des Genévriers 13705 LA |
| Address: | CIOTAT Cedex |
| Contact Person: | Kim ROUAHI |
| +33667690060 | |
| Product: | C50 |
| Name of Device: | Intraoral Camera |
| Common Name: | II |
| Regulatory Class: | 21 CFR 872.1745 - Laser, Fluorescence Caries Detection |
| Classification: | NBL |
| Product Codes: | |
| Predicate Device: | K121685 SOPROCARE |
| Device Description: | The C50 is an intraoral video camera equipped with LEDs to illuminate the inspection site. The C50 optics and its complementary metal oxide semiconductor (CMOS) sensor capture the natural fluorescence of the site under observation and convert the images into a video signal that is sent to the computer via a USB interface. The dental practitioner can use the images displayed on the computer screen as an aid in diagnosis. A USB Type-C (camera) to USB-A cable is provided to connect the C50 to a computer. The C50 provides the following functions: Aid in the detection of pit and fissure caries Information about patient dental hygiene Highlighting of dental plaque Highlighting of gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) Showing the difference between "before" and "after" care (follow-up). In CARIO mode (blue mode), the camera assists the dental practitioner by highlighting potential carious areas in pits and fissures on the occlusal surface of the teeth. In DAYLIGHT mode (white mode), the camera enables visualization of anatomical details invisible to the naked eye or with a mirror (thanks to its magnification). DAYLIGHT+ mode (white mode) is a shortcut version of DAYLIGHT mode where the contrast has been pushed from 20 to 70. In PERIO mode (yellow mode), the camera helps the dental practitioner to visualize dental plaque, in addition to highlighting areas of gingival inflammation (restricted to gingival inflammation that leads to bleeding upon probing). |
| Indications for Use: | C50 is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details invisible to the naked eye or with a mirror (thanks to magnification). |
| Technological Characteristics: | Subject and predicate devices are both manufactured by SOPRO. Predicate and subject device technological and performance characteristics are fundamentally the same, as shown by the following table. The subject device includes a device modification to add an additional mode, DAYLIGHT+ mode. |
{5}------------------------------------------------
| Predicate Device | Modified Device/ SubjectDevice | Discussion | |
|---|---|---|---|
| Manufacturer | SOPRO | SOPRO | - |
| Product Name | SOPROCARE | C50 | - |
| Common Name | Intraoral camera | Intraoral camera | - |
| ClassificationRegulation | 21 CFR 872.174521 CFR 872.1740 | 21 CFR 872.1745 | - |
| 510(k) Number | K121685 | K223470 | - |
| Indications for Use | SOPROCARE is intended forclinical practice of generaldentistry, as an aid in thediagnosis of pit and fissurecaries, as an aid to highlightdental plaque and gingivalinflammations (restricted togingival inflammations whichlead to bleeding upon probing)and as intra-oral camera tovisualize anatomical detailsinvisible to the naked eye orwith a mirror (thanks to itsmagnification). | C50 is intended for clinicalpractice of general dentistry,as an aid in the diagnosis of pitand fissure caries, as an aid tohighlight dental plaque and gingival inflammations(restricted to gingivalinflammations which lead tobleeding upon probing) and asintra-oral camera to visualizeanatomical details invisible tothe naked eye or with a mirror(thanks to its magnification). | Same |
| DEVICE DESIGN ANDUSE | |||
| Design | Image: SOPROCARE design | Image: C50 design | -- |
| Operational Modes | • CARIO• DAYLIGHT• PERIO | • CARIO• DAYLIGHT• PERIO• DAYLIGHT+ | The new DAYLIGHT+mode is similar toDAYLIGHT mode. Itoffers a higher-contrast image. Theremaining modesare identical. |
| Focus | 4 pre-set positions | Automatic focus or Singlefocus | The modified deviceincludes automaticfocus. The focusrange is similar forbothdevices. |
| Technology | Fluorescence technology | Fluorescence technology | Same |
| System of ImageCapture | Image capture button onhandpiece | Image capture button onhandpiece | Same |
| Accessories | • Intraoral tip• Dedicated protective sheath• Handpiece holder• USB cable | • Intraoral tip• Protective sheath (thirdparty)• Handpiece holder• USB cable | The C50 intraoralcamera is intendedfor use with legallymarketed protectivesheaths cleared byFDA as a barriersleeve for intraoralcameras. |
| User interface | 2 button keyboard for modeselection | 5 button keyboard for modeselection and on-screendisplay control | Similar |
| Power Supply | Docking station | USB | Different |
| IMAGING | |||
| Predicate Device | Modified Device | Discussion | |
| Light Source | LED | LED | Same |
| Returned Light | Standard image andfluorescence | Standard image andfluorescence | Same |
| Lens | Multiple lens system withoptical glass | Multiple lens system withoptical glass | Same |
| Sensor Resolution | NTSC | Full HD 1920 x 1080 | Different |
| PHYSICALCHARACTERISTICS | |||
| Dimensions | L = 200mm x W = 28mm x H =24mm | L = 200mm x W = 30mm x H =24mm | Similar |
| Weight | 100g | 78 g | Similar |
| Cable Length | 3 m | 2.5m | Similar |
| Workingtemperature | +10 °C / +40 °C | +10 °C / +35 °C | Similar |
| Working relativehumidity | 10% to 90% | 10% to 90% | Same |
{6}------------------------------------------------
Discussion: The modified C50 intraoral camera is very similar to the predicate device SOPROCARE in terms of design, size and weight specifications. Patient contacting materials of the modified and predicate devices are identical in formulation, manufacturing process, processing and geometry.
The On-Screen Display (OSD) of the C50 allows the device to be used with other imaging software (OIS), including Twain or Sopro SDK integration.
The subject device C50 offers Full HD resolution instead of the predicate NTSC resolution, thus enhancing image quality. The C50 is connected to a computer by means of a USB cable.
The C50 intraoral camera is intended for use with legally marketed protective sheaths cleared by FDA as a barrier sleeve for intraoral cameras (product code PEM).
Performance Design verification and validation testing to support determination of substantial equivalence Testing: consisted of the following tests:
- Comparison testing of image quality, sharpness, size, resolution, focus position and potential elevation in the temperature target tissue have been performed using the C50 and the third-party protective sheath and the accessory C50TIPS and have been shown to be substantially equivalent to the predicate device.
- Mechanical performance testing was performed on reprocessed C50TIPS to ensure that the device maintains its position on the C50 camera and completely blocks all external light.
- Mechanical testing was performed with regard to fit of the third-party protective sheath with the C50 and the accessory C50TIPS.
- . Electrical safety testing & EMC
Electrical (IEC 60601-1 and collateral standards) and EMC testing were conducted on the C50 device, consistent with the appropriate sections of the following current standards:
- o IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance and 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.
- o IEC/TR 60601-4-2 Medical Electrical Equipment Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
- Photobiological safety testing was conducted on the C50 device, consistent with the appropriate section of the following current standard: IEC 62471 Photobiological safety of lamps and lamp systems.
- Software validation was performed on the C50's firmware consistent with the appropriate section of the following current standard: IEC 62304 Software life cycle process.
{7}------------------------------------------------
- . Reprocessing validation testing was conducted on the C50, C50TIPS and USB cable in accordance with the recommendations outlined in FDA Guidance Document: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
- . Biocompatibility testing
The patient contact materials of C50TIPS were evaluated in accordance with the requirements of international standard ISO 10993-1 (Biological Evaluation of Medical Devices) and FDA Guidance Document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing within a Risk Management Process". The following biocompatibility tests were considered:
Chemical caracterization Cytotoxicity Acute Systemic Toxicity
Acceptance criteria were met for all tests performed.
- The subject device C50 and its accessories have the same intended use and similar Conclusion: technological characteristics as the predicate device SOPROCARE and the associated accessories. The information provided in this 510(k) submission indicates that the C50 intraoral camera and its accessories (intraoral tip, handpiece holder and USB cable) are substantially equivalent to the predicate device.
§ 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.