Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio

K143753 · Rayence Co., Ltd. · MUH · Mar 10, 2015 · Dental

Device Facts

• Record ID: K143753
• Device Name: Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio
• Applicant: Rayence Co., Ltd.
• Product Code: MUH · Dental
• Decision Date: Mar 10, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

EzSensor Soft [Alternative name : EzSensor Bio] Digital Dental Intra Oral Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

Device Story

Digital dental intra-oral sensor; collects dental x-ray photons; converts to electronic impulses; produces digital images. Used in dental clinics by dentists. Ergonomic design with soft silicon exterior for patient comfort. Connects via USB interface to computer running Easydent or EzDent i software. Software manages patient data, image acquisition, viewing, and consultation simulation. Provides high-resolution dental imaging for diagnostic assessment. Benefits include improved image quality, reduced radiation exposure compared to film, and enhanced patient comfort during intra-oral positioning.

Clinical Evidence

Bench testing only; no clinical trials. Performance evaluated via DQE, MTF, NPS, and CNR metrics, showing superior performance to predicate. 30 sets of radiographic images reviewed by a licensed dentist confirmed diagnostic quality and equivalence to predicate. Clinical images provided as supplemental evidence of system functionality.

Technological Characteristics

Digital intra-oral sensor; CMOS technology; amorphous silicon sensing layer with fluorescent material. USB 2.0 connectivity. Soft silicon exterior housing. Dimensions: Size 1.0 (37.5x26.5mm), Size 2.0 (43.5x32.5mm). Pixel pitch: 14.8μm. Software-based image processing (Easydent/EzDent i). Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for use by dentists to collect dental x-ray photons and convert them into electronic impulses for storage, viewing, and manipulation for diagnostic purposes.

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

• EzSensor (K090526)

Reference Devices

• EzDent i (K131594)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10, 2015

Rayence Co. Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025

Re: K143753

Trade/Device Name: EzSensor Soft [Alternative name : EzSensor Bio] digital dental image processing system Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 16, 2015 Received: February 23, 2015

Dear Mr. Kim:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K143753

#### Device Name

EzSensor Soft [Alternative name : EzSensor Bio] digital dental image processing system

Indications for Use (Describe)

EzSensor Soft [Alternative name : EzSensor Bio] Digital Dental Intra Oral Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

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

|× Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 807 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 1. 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date 510K summary prepared: February 16, 2015

Submitter's Name, address, telephone number, a contact person:

| Submitter's Name : | Rayence Co., Ltd. |
|-------------------------|---------------------------------------------------------|
| Submitter's Address: | 14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea |
| Submitter's Telephone: | [phone] |
| Contact person: | Mr. Kee Dock Kim / RA Team Manager / [phone] |
| Official Correspondent: | Dave Kim ([e-mail]) |
| (U.S. Designated agent) | |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone: | [phone] |
| Fax: | [phone] |

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

| Trade/proprietary name: | EzSensor Soft [Alternative name : EzSensor Bio] |
|-------------------------|-------------------------------------------------|
| Common Name: | Digital Dental Intra Oral Sensor |
| Regulatoin number: | 21 CFR 872.1800 |
| Regulation name: | Extraoral source X-ray system |
| Product Code: | MUH |
| Predicate Device : | |
| Manufacturer | : Rayence Co., Ltd. |
| Device | : EzSensor |
| 510(k) Number | : K090526 (Decision Date – DEC. 2. 2009) |

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# 2. Device Description

EzSensor Soft[Alternative name : EzSensor Bio] Digital Dental Intra Oral Sensor is a device which acquires digital intra oral images. Direct digital systems acquire images with a flexible sensor that is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems is the speed with which images are acquired. For patient comfort, the ergonomic design is based on human intraoral anatomy.

- · Excellent image quality based on advanced CMOS technology
- · Sensor's ergonomic shape is more comfortable for the human oral structure
- · Lower dose exposure (compared to film sensor)
- Enhanced durability
- Easy-to-use USB interface

# 3. Indication for use

EzSensor Soft [Alternative name : EzSensor Bio] Digital Dental Intra Oral Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

# 4. Summary of Design Control Risk management

The risks and the hazardous impact of the device modification were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented in the new product design phase. The overall assessment concluded that all risks and hazardous conditions identified arising from the design change were successfully mitigated and accepted.

# 5. Summary of the technological characteristics of the device compared to the predicate device

The EzSensor Soft [Alternative name : EzSensor Bio] Digital Dental Intra Oral Sensor described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device, EzSensor of Rayence Co., Ltd.

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## 5. 1 Feature

The mechanical design for each device is different as following.

Image /page/6/Figure/2 description: The image shows two diagrams of the EzSensor. The top diagram is labeled "Proposed: EzSensor Soft [Alternative name: EzSensor Bio]" and shows a USB port labeled A, a component labeled B, and a sensor labeled C. The bottom diagram is labeled "Predicate: EzSensor" and also shows a USB port labeled A, an interface board labeled B, and a sensor labeled C.

### Differences

| Proposed | Predicate |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| B 1) Improved the user grip by designing the interface board housing slim to reduce the possibility of dropping the sensor.<br>2) The holder for the sensor housting makes it easily portable. | The interface board is larger. |
| C Soft silicon material surrounds the moudule to reduce the discomfort when it is positioned inside the mouth compared to the predicate device. | The aluminum case caused a pain and discomfort when it was placed inside the mouth of a patient. |

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EzSensor Soft [Alternative name : EzSensor Bio] The potential risks (electroic shock, device failure, misdiagnosis, tissue damage, serious leakage current, etc...) were analyzed by conducting complete verification for IEC/EN 60601-1 and drop & vibration test. (Completed the risk analysis for A,B,C above).

While applying the sensor exterior with soft silicon material reduced the oral discomfort or pain, additional risk analysis was conducted to mitigate the potential risks that may arise with respect to leakage current, sensor fracture or breakage, and cable disconnection. The risk mitigation measures were satisfactory to manage the new risks identified and the residual risks were within acceptable limits.

| Characteristic | Proposed<br>Rayence Co., Ltd.<br>EzSensor Soft<br>[Alternative name : EzSensor Bio] | | Predicate<br>Rayence Co., Ltd.<br>EzSensor |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Image: EzSensor Soft | | Image: EzSensor |
| 510(k) number | K150212 | | K090526 |
| Indications<br>for use | EzSensor Soft<br>[Alternative name : EzSensor Bio]<br>Digital Dental Intra Oral Sensor is<br>intended to collect dental x-ray<br>photons and convert them into<br>electronic impulses that may be<br>stored, viewed and manipulated for<br>diagnostic use by dentists. | | EzSensor, an Intra-oral Imaging<br>System, is intended to collect dental<br>x-ray photons and convert them<br>into electronic impulses that may<br>be stored, viewed, and manipulated<br>for diagnostic use by dentists. |
| Sensor<br>Dimension(mm) | Size "1.0": 37.5 x 26.5<br>Size "2.0": 43.5 x 32.5 | | Size "1.0": 35.7 x 25.2<br>Size "1.5": 38.7 x 29.2 |
| Sensor Thickness | 5 | | 4.9 |
| Active Area(mm) | Size "1.0": 20 x 30<br>Size "2.0": 25.99 x 35.99 | | Size "1.0": 20.02 x 30.03<br>Size "1.5": 24.08 x 31.85 |
| Pixel Pitch(μm) | 14.8 | | 35 |
| SB Module | Integrated USB 2.0 module | | Integrated USB 2.0 module |
| | Full Resolution | 14.8 | 35 |

### 5. 2 Characteristic

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| Pixel Pitch(μm) | Binning Mode | 29.6 | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|------------------------------------------------------------------------------------------------------|
| <i>DQE</i> (6 lp/mm) | Full Resolution | 0.199 | |
| | Binning Mode | 0.199 | 0.123 |
| <i>MTF</i> (6 lp/mm) | Full Resolution | 0.436 | 0.382 |
| | Binning Mode | 0.464 | |
| Typical dose<br>range(μGy) | Incisor & Canine : 300 ~ 500 / Molar: 400 ~ 600 | | |
| Active Pixel Array | Size 1.0: 1352 x 2028 pixels<br>(30 x 20 mm)<br>676 x 1014 pixels @ binning mode<br>Size 2.0: 2432 x 1756 pixels<br>(35.99 x 25.99 mm)<br>1216 x 878 pixels @ binning mode | | Size 1.0: 572 x 858 pixels<br>(20.02 x 30.03 mm)<br>Size 1.5: 686 x 944 pixels<br>(24.01 x 33.04 mm) |

### 5. 3 Viewer Software

| Characteristic | Proposed<br>Rayence Co., Ltd.<br>EzSensor Soft<br>[Alternative name : EzSensor Bio] | Predicate<br>Rayence Co., Ltd.<br>EzSensor |
|-----------------|-------------------------------------------------------------------------------------|--------------------------------------------|
| Viewer Software | Easydent & EzDent i | Easydent |

This device is operated using viewer software. With the identical hardware configuration, the model name is distinguished by the type of image viewing software available. The software functions include the patient information management, image capture, and viewer for captured images.

| Viewer Software | 510(k) Number | Manufacturer |
|-----------------|---------------|-------------------|
| Easydent | - | Rayence Co., Ltd. |
| EzDent i | K131594 | EWOO SOFT |

Easydent and EzDent i image viewing software have the same functionality and performance. The main difference is the design of the user interface (UI) and new consulting simulation tool for EzDent i. EzDent i requires a fee based license registration for the right to use whereas Easydent is provided free of charge.

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# 5.4 Difference for Easydent and EzDent i

| | Easydent | EzDent i |
|--------------------------------|----------------------------------------------------------|---------------------------------------------------------------------|
| Function | Patient<br>View<br>Acquisition<br>Consultation<br>Report | Patient<br>View<br>Acquisition<br>Consultation<br>Report<br>License |
| The initial<br>screen shot | Image: Easydent initial screen | Image: EzDent i initial screen |
| Image<br>Acquisition<br>screen | Image: Easydent acquisition screen | Image: EzDent i acquisition screen |

# 5.5 Features added to EzDent i

# 5.5.1. Acquisition_ CONSULT Tab

Acquisition_ CONSULT Tab is a consulting tool and provides a video simulation of the treatment process with the acquired images in sequence.

Image /page/9/Picture/5 description: The image shows a dental software interface with a focus on dental imaging and treatment planning. On the left, there is a panel with options like 'Favorites' and 'Recent List', suggesting image organization features. The central part of the interface displays a dental X-ray, while the right side shows a 3D model of a tooth undergoing a root canal procedure. At the bottom, there is a timeline or sequence of images related to the root canal treatment, indicating a step-by-step guide or visual aid for dental professionals.

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### 5.5.2. License

EzDent i requires a fee based license registration for the right to use whereas EasyDent is provided free of charge.

## 6. Proposed Labeling- Changes in comparison to the predicate device

| Proposed | Predicate |
|-------------------------------------------------------------------------|-------------------------------|
| Rayence Co., Ltd.<br>EzSensor Soft<br>[Alternative name : EzSensor Bio] | Rayence Co., Ltd.<br>EzSensor |

| Rayence Co.,Ltd.<br>14, Samsung 1-ro 1-gil, Hwaseong-si,<br>Gyeonggi-do, Korea www.rayence.com | Rayence Co., Ltd.<br>14, Samsung 1-ro 1-gil, Hwaseong-si,<br>Gyeonggi-do, Korea www.rayence.com |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| • Product Name : Medical Image Processing Unit | • Product Name : Medical Image Processing Unit |
| • Model Name : EzSensor Soft | • Model Name : EzSensor |
| • Rating : 5V, 500mA | |
| SN | SN |
| REF | REF R-USM-701 |
| | IP Class:IPX0 |
| This equipment complies with IEC 60601-1, IEC 60601-1-2 and 21CFR Subchapter J | |
| EC REP | EC REP |
| VATECH Dental Manufacturing Ltd.<br>Chancery House, St. Nicholas Way, Sutton, SM1 1JB UK<br>Tel: [phone] Fax: [phone]<br>Made in KOREA | VATECH Dental Manufacturing Ltd.<br>Chancery House, St. Nicholas Way, Sutton, SM1 1JB UK<br>Tel: [phone] Fax: [phone]<br>Made in KOREA |

| Rayence Co.,Ltd<br>14, Samsung 1-ro 1-gil, Hwaseong-si,<br>Gyeonggi-do, Korea www.rayence.com |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| • Product Name : Medical Image Processing |
| • Model Name : EzSensor Bio |
| • Rating : 5V, 500mA |
| SN |
| REF |
| EC REP |
| VATECH Dental Manufacturing Ltd.<br>Chancery House, St. Nicholas Way, Sutton, SM1 1JB UK<br>Tel: [phone] Fax: [phone]<br>Made in KOREA |

# 7.Summary of Performance Testing

The intended use, application and detector type of EzSensor Soft[Alternative name : EzSensor Bio] is the same as that of the predicate device, EzSensor Soft[Alternative name : EzSensor Bio] and EzSensor use the same amorphous silicon alley and materials for fluorescent as the sensing means. The performance test result indicates that the EzSensor Soft[Alternative name : EzSensor Bio] detector outperformed EzSensor (the predicated device ) in terms of DQE, MTF, and NPS. No additional safety risk is identified in the bench test: SSXI report.

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With a smaller measured pixel size of EzSensor Soft, both in full resolution and in 2x2 binning mode, DQE, MTF, and NPS test demonstrated that EzSensor Soft has better performance results than EzSensor, the predicate sensor.

Especially, the response of EzSensor Soft (alternatively, EzSensor Bio) as a function of X-ray exposure is very linear and has better linearity than EzSensor in the same dynamic range.

The EzSensor Soft intra oral sensor improved the noise performance and superior CNR characteristics compared to EzSensor, the predicate device. Lower the contrast-to-noise ratio (CNR), it is less able to represent a fine shade of the lesion. The superior CNR performance of EzSensor Soft compared to EzSensor is the direct result of the Noise improvement.

The pixel pitch of EzSensor Soft(Proposed) is smaller than one for EzSensor(Predicate) and the difference between the resolution is expected to be large. However, final images generated by both new and predicate sensors are subject to post processing (image enchangement) image optimization with the noise improvement and maximization of signal-to-noise ratio. Therefore the new sensor images are similar or moderatly superior to existing EzSensor (Predicate).

Total 30 sets of radiographic images were reviewed by a licensed dentist. Based on the reviewer's conclusion, EzSensor Soft[Alternative name : EzSensor Bio] (Full Resolution Mode) more closely matches EzSensor. In addition, images of EzSensor Soft[Alternative name : EzSensor Bio] in full resolution mode is generally more sharper and clearer than EzSensor Soft[Alternative name : EzSensor Bio] in binning mode.

All images present no difficulty in evaluating a range of antomic structures necessary to provide a correct conclusion while minimizing radiation exposure to patients.

Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device. However they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.

### 9. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Rayence Co., Ltd. concludes that EzSensor Soft [Alternative name : EzSensor Bio] is safe and substantially equivalent to predicate device as described herein.