INTRAORAL BELSENSOR GOLD

K102456 · Takara Belmont USA, Inc. · MUH · Dec 15, 2011 · Dental

Device Facts

• Record ID: K102456
• Device Name: INTRAORAL BELSENSOR GOLD
• Applicant: Takara Belmont USA, Inc.
• Product Code: MUH · Dental
• Decision Date: Dec 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The BelSensor GOLD is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images. The BelSensor GOLD shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The BelSensor GOLD can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of a patient.

Device Story

BelSensor GOLD is an indirect-converting digital X-ray detector for dental intra-oral imaging. Device uses a scintillator to convert incident X-rays into visible light, which is then captured by a CMOS-based light detection imager. System connects to a personal computer via USB 2.0. Operated by trained healthcare professionals in a clinical setting; sensor is placed in the patient's mouth, either manually or using positioning devices, to capture radiographs. Output is a digital image displayed on a PC for diagnostic review by the clinician. Device facilitates dental diagnosis by providing high-resolution intra-oral images.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical, mechanical, and environmental safety testing (IEC 60601-1), EMC testing (IEC 60601-1-2), and biocompatibility testing of cable and housing materials per USP guidelines.

Technological Characteristics

Indirect-converting digital X-ray detector; CMOS sensor technology; USB 2.0 interface. Available in two sensor sizes (30x20mm, 36x26mm). Dynamic range 15,000:1. Biocompatible housing and cable materials. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), USP (biocompatibility).

Indications for Use

Indicated for dental intra-oral radiology image acquisition in patients requiring dental radiographs. Intended for use by trained healthcare professionals.

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 Sensor (K090458)

Submission Summary (Full Text)

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# 510(k) Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is Kload S6

### Submitter Information (21 CFR 807.92(a)(1))

Submitter:

ﻨﺎ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

Takara Belmont USA, Inc.

Belmont Equipment Division

101 Belmont Drive

Somerset, NJ 08873-1204

| Contact Person: | Robert Schiff |
|-----------------|-----------------|
| Telephone: | 973-227-1830 |
| Summary Date: | August 20, 2010 |

#### Device Name/Classification (21 CFR 807.92(a)(2))

| Proprietary Name: | Intraoral BelSensor GOLD |
|----------------------|---------------------------------------------------------------|
| Common/Usual Name: | Digital X-ray Sensor |
| Classification Name: | Class II Extraoral source x-ray system, per 21 CFR § 872.1800 |
| Classification Code: | MUH |

Substantially Equivalent/Predicate Devices (21 CFR 807.92(a)(3))

Predicate Device 1: Dexis Sensor (K090458)

#### Device Description (21 CFR 807.92(a)(4))

The BelSensor GOLD is an indirect converting x-ray detector that converts incident xrays by a scintilator into visable light, which is coupled optically to a light detection imager based on CMOS technology. Incident x-rays are automatically detected to generate digital images for dental intra-oral applications.

The BelSensor GOLD supports USB 2.0 connectivity to personal computer.

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### Device Intended Use (21 CFR 807.92(a){5))

The BelSensor GOLD is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images. The BelSensor GOLD shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The BelSensor GOLD can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of a patient.

## Technological Characteristics (21 CFR 807.92(a)(6))

Comparison of the Principal Characteristics of the Belmont BelSensor and the DEXIS Sensor ·

| Descriptive<br>Information | Belmont BelSensor GOLD | Dexis Sensor<br>(K090458) |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The BelSensor GOLD is a USB-<br>driven digital sensor which is<br>intended to acquire dental intra-<br>oral radiology images. The<br>BelSensor GOLD shall be<br>operated by healthcare<br>professionals, who are educated<br>and competent to perform the<br>acquisition of dental intra-oral<br>radiographs. The BelSensor<br>GOLD can be used either in<br>combination with special<br>positioning devices to facilitate<br>positioning and alignment with the<br>x-ray beam or it may also be<br>positioned by hand with the<br>assistance of a patient. | The DEXIS sensor is a USB-driven<br>digital sensor which is intended to<br>acquire dental intra-oral radiology<br>images. The DEXIS sensor shall<br>be operated by healthcare<br>professionals, who are educated<br>and competent to perform the<br>acquisition of dental intra-oral<br>radiographs. The DEXIS sensor<br>can be used either in combination<br>with special positioning devices to<br>facilitate positioning and alignment<br>with the x-ray beam or it may also<br>be positioned by hand with the<br>assistance of a patient. |
| Number of<br>Sensors | 2 | 1 |
| Sensor Size (mm) | 30 x 20<br>36 x 26 | 30 x 39 |
| Technology | CMOS | CMOS |
| Interface with PC | USB | USB |
| Dynamic Range | 15,000:1 | 16,384:1 |
| Sensor Cable<br>Length (m) | 3 | 2.8 |

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## Safety, EMC, Biocompatability and Performance Data

Electrical, mechanical, environmental safety and performance testing according to IEC 60601-1 (2005) was performed, and EMC testing was conducted in accordance with standard IEC 60601-1: 1988 + A1: 1991 + A2:1995, IEC 60601-1:2005 (without 60601-1-6), EN 60601-1: 2006, (without 60601-1-6), EN 60601-1-2: 2007.

Biocompatability for the cable and housing material was conducted under USP testing guidelines. Detailed information can be found in Attachment 7.

Conclusion: The Belmont BelSensor GOLD is substantially equivalent to other legally marketed devices in the United States. The Belmont BelSensor GOLD is substantially equivalent in intended use and technical characteristics to the DEXIS Sensor marketed by Sybron Dental Specialties, Inc.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Takara Belmont USA. Inc. % Robert Schiff, Ph.D., RAC, COA, FRAPS President and CEO Schiff & Company 1129 Bloomfield Avenue WEST CALDWELL NJ 07006

DEC 1 5 2011

Re: K102456

Trade/Device Name: BelSensor GOLD Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: November 10, 2011 Received: November 14, 2011

Dear Dr. Schiff:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Salety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | Not assigned yet K102456 |
|---------------------------|--------------------------|
| Device Name: | BelSensor GOLD |

Indications for Use: The BelSensor GOLD is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images. The BelSensor GOLD shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The BelSensor GOLD can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of a patient.

| Prescription Use | X | Over-The-Counter Use | _________________ |
|----------------------------|---|------------------------|-------------------|
| (Per 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

510K: K102456

SUBMITTED BY SCHIFF & COMPANY, WEST CALDWELL, NJ

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