SensorX

K203116 · Durr Dental SE · MUH · Mar 19, 2021 · Dental

Device Facts

• Record ID: K203116
• Device Name: SensorX
• Applicant: Durr Dental SE
• Product Code: MUH · Dental
• Decision Date: Mar 19, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The intraoral sensor is intended to convert x-ray photons into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

Device Story

SensorX is an intraoral x-ray sensor for dental applications; detects x-rays and performs image acquisition; digitizes image for PC storage/viewing. Device consists of sensor head connected via cable to computer; requires protective barrier sheaths for patient use. Operated by dentists/dental professionals in clinical settings. Imaging software (VisionX or DBSWIN) activates sensor and displays images almost instantaneously. Provides high-resolution images with minimal radiation dose. Benefits include rapid image acquisition for diagnostic decision-making.

Clinical Evidence

Bench testing only. No clinical data required. Evidence includes compliance with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), and IEC 60601-2-65 (dental X-ray equipment). Biocompatibility assessed via EN ISO 10993-5. Dental images provided to demonstrate resolution and contrast.

Technological Characteristics

CMOS-based intraoral sensor; Cesium Iodide (CsI) scintillator; USB 2.0 connectivity; 5.0V/0.5W power via USB. Dimensions vary by size (e.g., 37.0x25.2mm to 44.7x33.1mm). Features include binning, gain/offset/pixel calibration, and noise filtering. Complies with IEC 60601-1, 60601-1-2, 60601-1-6, and 60601-2-65.

Indications for Use

Indicated for dentists to acquire dental intraoral radiographic images for diagnostic use.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) (K172918)

Reference Devices

• VisionX (K192743)
• DBSWIN (K203287)
• TIDIShield Digital x-ray sensor sheaths (K132953)
• Digital sensor cover/sleeve (K151123)

Submission Summary (Full Text)

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March 19, 2021

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Durr Dental SE % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K203116

Trade/Device Name: SensorX Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: February 4, 2021 Received: February 9, 2021

Dear Mr. Kamm:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 ([e-mail]) or phone [phone] 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) K203116

Device Name SensorX

Indications for Use (Describe)

The intraoral sensor is intended to convert x-ray photons into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

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

| <div style="display:flex; align-items:center;"> <input checked="" type="checkbox"/> Research Use (Per 21 CFR 601.2 and D) </div> |
|------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"> <input type="checkbox"/> Commercial Use (21 CFR 601.2) </div> |

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary, DÜRR DENTAL SE K203116

This Traditional 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92 and the FDA Guidance "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" issued on September 1, 2016.

#### Date Summary Prepared: February 4, 2021 1.

#### 2. Submitter's Identification:

| Submitter's Identification: | DÜRR DENTAL SE<br>Höpfigheimer Str. 17<br>74321 Bietigheim-Bissingen<br>Germany<br>Phone: + 49 (0) 7142 70 5-0<br>Fax: + 49 (0) 7142 705-500<br>E-Mail: [e-mail]<br>www.duerrdental.com | Establishment Registration Name<br>in FURLS:<br>Duerr Dental SE |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Establishment Registration<br>Number: | 3015509619 | |
| Submitter's Contact: | Mr. Oliver Lange<br>Director of Quality Management<br>DÜRR DENTAL SE<br>Höpfigheimer Str. 17<br>74321 Bietigheim-Bissingen,<br>Germany<br>Phone: + 49 (0) 7142 70 5-190<br>Email: [e-mail] | |
| U.S. Agent & Contact: | Mr. Joseph Latkowski<br>Director of Quality and Regulatory<br>Air Techniques, Inc.<br>1295 Walt Whitman Road<br>Melville, NY 11747, USA<br>U.S. Phone: [phone]<br>E-Mail: [e-mail] | |

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#### Identification of Subject Device: 3.

| Trade /Proprietary Name: | SensorX |
|-------------------------------|------------------------------------------|
| Device: | System, x-ray, extraoral source, digital |
| Regulation Description: | Extraoral source x-ray system |
| Regulation Medical Specialty: | Dental |
| Review Panel: | Radiology |
| Product Code: | MUH |
| Regulation Number: | 872.1800 |
| Device Class: | II |

#### 4. Predicate Device

| 510(k) Number: | K172918 |
|-------------------------------|----------------------------------------------|
| Manufacturer: | KaVo Dental Technologies, LLC |
| Trade /Proprietary Name: | DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) |
| Device: | System, x-ray, extraoral source, digital |
| Regulation Description: | Extraoral source x-ray system |
| Regulation Medical Specialty: | Dental |
| Review Panel: | Radiology |
| Product Code: | MUH |
| Regulation Number: | 872.1800 |
| Device Class: | II |

#### Device Description 5.

The subject device SensorX device is an intraoral x-ray sensor for dental applications. It detects the x-rays and performs the image acquisition, digitizes the image and makes it available for the x-ray sensor is connected to the computer via the sensor cable, and if required, the USB extension.

The x-ray sensor is equipped with protective cover sheaths (previously 510(k) cleared) and placed in the mouth of the patient. For patient comfort, the ergonomic design is based on human intraoral anatomy:

Image /page/4/Picture/7 description: In the image, a woman is undergoing a medical procedure involving a device inserted into her mouth. The device consists of a circular frame positioned around her face, with a tube extending into her mouth. The woman's face is visible in profile, showing her eye, nose, and mouth. The background is a plain wall.

Image /page/4/Picture/8 description: In the image, a woman is undergoing a dental X-ray procedure. The X-ray machine is positioned near her mouth, capturing images of her teeth and jaw. The woman appears calm and cooperative as the dental professional operates the machine. The image likely aims to showcase the technology and process involved in dental X-rays.

Image /page/4/Picture/9 description: In the image, there are two close-up shots of people's arms. In the left image, a person's arm is positioned under a piece of medical equipment. The right image shows a person's arm with a white wire attached to it.

Figure 1 – SensorX application

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SensorX enables high resolution with a minimum radiation dose. It is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems such as SensorX, is the speed with which images are acquired. SensorX is activated via the imaging software VisionX (K192743) OR DBSWIN (K203287).

#### 6. Indications for use.

The intraoral sensor is intended to convert x-ray photons into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

#### 7. Description of Substantial Equivalence: Technological Characteristics:

The device comparison table below compares the Predicate Device: K172918 KaVo Dental Technologies, LLC to our proposed SensorX devices. Our device has the same intended use and technological characteristics as compared to the predicate device. The small differences do not raise any questions of substantial equivalence. The physical sizes are similar. The technologies are nearly identical. The required computer and computer interfaces are identical. Therefore the DÜRR DENTAL SE SensorX is substantially to the equivalent KaVo device.

#### 8. Summary of the technological characteristics compared to the predicate devices

| Characteristics: | Predicate Device:<br>K172918<br>KaVo Dental Technologies, LLC | | | Subject Device:<br>DÜRR DENTAL SE | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Device Name | DEXIS Titanium | KaVo IXS HD<br>Size 1 | KaVo IXS<br>HD Size 2 | SensorX<br>Size 1 | SensorX<br>Size 2 |
| Indications for Use | The DEXIS / KaVo sensor is a USB-driven<br>digital sensor which is intended to<br>acquire dental intraoral radiographic<br>images. The DEXIS / KaVo sensor shall be<br>operated by healthcare professionals,<br>who are educated and competent to<br>perform the acquisition of dental intra-<br>oral radiographs. The DEXIS / KaVo<br>sensor can be used either in combination<br>with special positioning devices to<br>facilitate positioning and alignment with<br>the x-ray beam or it may be also<br>positioned by hand with assistance of the<br>patient. | | | The intraoral sensor is intended to<br>convert x-ray photons into electronic<br>impulses that may be stored, viewed<br>and manipulated for diagnostic use by<br>dentists.<br>(Same indication as predicate but<br>simplified wording) | |

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| Characteristics: | Predicate Device:<br>K172918<br>KaVo Dental Technologies, LLC | Subject Device:<br>DÜRR DENTAL SE |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Picture | Image: DEXIS Titanium / KaVo IXS HD Intraoral Sensors | Image: SensorX device |
| Device Description | The DEXIS Titanium / KaVo IXS HD<br>Intraoral Sensors are an indirect<br>converting x-ray detector, e.g. incident x-<br>rays are converted by a scintillating<br>material into (visible) light, this light is<br>coupled optically to a light detection<br>imager based on CMOS technology. The<br>design of the sensor assembly supports<br>the automatic detection of the incident<br>x-rays to generate digital images for<br>dental intra oral applications. The DEXIS<br>Titanium / KaVo IXS HD Intraoral Sensors<br>support USB2.0 connectivity to personal<br>computers using a dedicated electronic<br>assembly and a sensor software driver. | The subject device SensorX device is<br>an intraoral x-ray sensor for dental<br>applications. It detects the x-rays and<br>performs the image acquisition,<br>digitizes the image and makes it<br>available for the PC. The x-ray sensor is<br>connected to the computer via the<br>sensor cable, and if required, the USB<br>extension. The x-ray sensor is<br>equipped with protective cover<br>sheaths (previously 510(k) cleared)<br>and placed in the mouth of the<br>patient. For patient comfort, the<br>ergonomic design is based on human<br>intraoral anatomy. |

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| Characteristics: | Predicate Device:<br>K172918<br>KaVo Dental Technologies, LLC | Subject Device:<br>DÜRR DENTAL SE | | | |
|------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------|---------------------------------------------|
| | | SensorX enables high resolution with a<br>minimum radiation dose. It is<br>connected to a computer to produce<br>an image almost instantaneously<br>following exposure. The primary<br>advantage of direct sensor systems<br>such as SensorX, is the speed with<br>which images are acquired. SensorX is<br>activated via the imaging software<br>VisionX (K192743) or DBSWIN<br>(K203287). | | | |
| Fundamental<br>Technology | CMOS | CMOS | | | |
| Sensor Exterior<br>Dimension (mm) | 39.9 x<br>29.8 | 37.0 x<br>25.2 | 42.3 x<br>30.4 | 39.0 x 27.4 | 44.7 x 33.1 |
| Sensor Active Imaging<br>Area (mm) | 33.0 x 26.0<br>with four<br>clipped<br>corners | 30.1 x 20.2<br>with four<br>clipped<br>corners | 36.0 x<br>26.0<br>with four<br>clipped<br>corners | 30.0 x 20.0<br>with four clipped<br>corners | 36.0 x 26.0<br>with four clipped<br>corners |
| Pixel Size (μm) | 19.5 | | | 19 | |
| Dynamic Range | 4,096:1 | | | 4,096:1 | |
| Image Resolution | 1692 x 1324<br>pixels | 1539 x<br>1026 pixels | 1842 x<br>1324<br>pixels | 1580 x 1050 pixels | 1896 x 1368<br>pixels |
| USB Cable Exit | 35° angled<br>cable exit | 0° parallel<br>cable exit | 0°<br>parallel<br>cable exit | 0° parallel cable exit | |
| Corner Design | Chamfered<br>corners | Rounded<br>corners | Rounded<br>corners | Chamfered corners | |
| Sensor Cable Length | 3 m | | | 2.5 m | |
| X-ray Resolution | 20+ visible lp/mm | | | 20+ visible lp/mm | |
| Scintillator Technology | Cesium Iodide (CsI) Scintillator | | | Cesium Iodide (CsI) Scintillator | |
| SW Features | USB 2.0 Communication<br>Noise Filtering | | | USB 2.0 Communication<br>Noise Filtering | |

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| Characteristics: | Predicate Device:<br>K172918<br>KaVo Dental Technologies, LLC | Subject Device:<br>DÜRR DENTAL SE |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Binning Basic Image Correction<br>(Gain/offset/pixel Calibration) Monitoring Sensor Health/State Image Transmission | Binning Basic Image Correction<br>(Gain/offset/pixel Calibration) Monitoring Sensor Health/State Image Transmission |
| Interface to PC | USB Type A Plug | USB Type A Plug |
| Input Electrical Power | 5.0 V / 0.5 W via USB | 5.0 V / 0.5 W via USB |
| Exposure Method | X-Ray Monitor Mode | X-Ray Monitor Mode |
| Communication<br>Standard<br>(USB Model) | USB 2.0 | USB 2.0 |
| Motion Sensing<br>Compatibility | Yes | Yes |
| Consensus Standards | IEC 60601-1 Basic Safety<br>IEC 62366-1 Usability<br>IEC 60601-2-65 Dental intra-oral X-ray<br>equipment<br>IEC 60601-1-2 Electromagnetic<br>Compatibility<br>IEC 62304 (Software testing<br>requirements) | IEC 60601-1 Basic Safety<br>IEC 60601-1-6 Usability<br>IEC 60601-2-65 Dental intra-oral X-ray<br>equipment<br>IEC 60601-1-2 Electromagnetic<br>Compatibility<br>IEC 62304 (Software testing<br>requirements: Companion software<br>sold separately, see chart below) |

### Imaging Software:

| Imaging Software to be<br>used with the Subject<br>Device (SensorX): | 510(k)<br>Number: | Manufacturer: | Distributor |
|----------------------------------------------------------------------|-------------------|--------------------------------------------------------------------------|------------------------|
| VisionX | K192743 | DÜRR DENTAL SE In the 510(k) database<br>referred to as "Durr Dental SE" | Air Techniques<br>Inc. |
| DBSWIN | K203287 | DÜRR DENTAL SE In the 510(k) database<br>referred to as "Durr Dental SE" | Air Techniques<br>Inc. |

Protective covers sheaths must be used before placing the SensorX into the patient's mouth. After usage the device must be cleaned and disinfected using the disinfectants and cleaning agents as listed in the installation and operating instructions.

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## Accessories to be used with the Subject Device (SensorX):

| Barrier Sleeves / Barrier Envelopes: | 510(k)<br>Number: | Manufacturer: | |
|------------------------------------------|------------------------------------------------------------------|--------------------|------------------------------|
| TIDIShield® Digital x-ray sensor sheaths | K132953 | TIDI PRODUCTS, LLC | |
| 100S | Digital sensor cover, 1 3/8" X 8", 500/box | K151123 | Pac-Dent International, Inc. |
| 100L | Digital sensor sleeve, 1 5/8" X 8", 500/box | K151123 | Pac-Dent International, Inc. |
| DX-405 | Fits Gendex Size 1, XDR size 1, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| DX-406 | Fits Gendex Size 2, XDR Size 2, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| DX-999 | Fits Dexis, Compares to TIDI # 20999, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| DX-978 | Fits Kodak 6100 Size 1, Compares to TIDI # 20978, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| DX-979 | Fits Kodak 6100 Size 2, Compares to TIDI # 20979, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| DX-890 | Fits Sirona Size 2, Compares to TIDI # 20890, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| DX-904 | Fits Sirona Size 1, Compares to TIDI # 20904, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| DX-824 | Fits Schick Size 1, Compares to TIDI # 20824, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| DX-825 | Fits Schick Size 2, Compares to TIDI # 20825, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| DX-819 | Fits Suni/Lightyear Size 2, Compares to TIDI # 20819, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| PPE-248-2 | #2 Barrier envelopes, 100pcs/box | K151123 | Pac-Dent International, Inc. |

#### 9. Non-Clinical Data and Performance Testing

A clinical evaluation was performed. Furthermore, testing to the following IEC and DIN Standards was completed successfully:

| Standard: | Standard Title: | Compliance Report Provided: |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| IEC 14971 | Medical devices – Application of risk<br>management to medical devices | • Risk Analysis |
| IEC 60601-1 | Medical Electrical Equipment, Part I:<br>General requirements for basic safety<br>and essential performance | • IEC 60601-1 Safety Test Report |
| IEC 60601-1-2 | Medical Electrical Equipment, Part I-2:<br>General requirements for basic safety<br>and essential performance. Collateral<br>Standard: Electromagnetic Compatibility | • IEC 60601-1-2 EMC Test Report |
| IEC 60601-1-6 | General requirements for basic safety<br>and essential performance – Collateral<br>standard: Usability | • IEC 60601-1-6 Test Report |
| IEC 60601-2-65 | Medical electrical equipment - Part 2-<br>65: Particular requirements for the basic | • User Manual |

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| Standard: | Standard Title: | Compliance Report Provided: |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | safety and essential performance of<br>dental intra-oral X-ray equipment<br><i>Applicable sections for Sensor devices:</i><br>• 201.7.9.1<br>• 203.6.7.4 | • Computer System Requirements |
| Software: | | |
| System Integration<br>Testing | Subject device integration was<br>evaluated in accordance with the FDA<br>Guidance for the Content of Premarket<br>Submissions for Software Contained in<br>Medical Devices. Risk management<br>activities were documented. | • Cybersecurity for digital devices<br>• Software System Test Report (Imaging<br>Software: VisionX 2.4.10)<br>• Software separately reviewed and<br>cleared by FDA. |
| Reprocessing: | | |
| Cleaning the device | Although the sensor does not normally<br>come into contact with the patient,<br>incidental contact is possible. | • Validation Report – Manual Reprocessing<br>• User Manual Instructions |
| Biocompatibility: | | |
| EN ISO 10993-5 | Biological Evaluation Report | • Biological Risk Assessment<br>• The device does not come into direct<br>contact with the patient. A separate FDA<br>cleared disposable plastic barrier is used. |

# In addition to the tests and reports cited above, actual dental images were provided which showed excellent resolution and contrast.

## 10. Clinical Data

Clinical data is not required for a finding of substantial equivalence.

## 11. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the similarity to the predicate device in terms of technology, performance and indications for use, DÜRR DENTAL SE concludes that the SensorX is substantially equivalent to the predicate device as described herein. The differences between the new device and the predicate device shown in the comparison table above do not raise any new questions about safety and effectiveness and so we consider it substantially equivalent to the predicate device.