DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM

K060640 · Dentamerica · EHD · Apr 24, 2006 · Dental

Device Facts

• Record ID: K060640
• Device Name: DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM
• Applicant: Dentamerica
• Product Code: EHD · Dental
• Decision Date: Apr 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Digirex™ Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. A digital sensor rather than film is used to capture x-rays from an external source and produce digital images of a patient's mouth. The digital sensor and the USB controller allow the images to be transferred to a computer for analysis, archiving and electronic transmission.

Device Story

Digirex™ Digital Dental Radiography System replaces traditional film x-ray imaging; utilizes digital sensor to capture x-rays from external source; USB controller transfers images to computer for analysis, archiving, and electronic transmission. Used in dental clinical settings; operated by dental professionals. Eliminates need for darkroom/chemicals; enables instantaneous image viewing; reduces patient radiation dose compared to film. Healthcare providers use digital images for diagnostic assessment of patient's mouth.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital sensor and USB controller; captures x-rays from external source; produces digital images; connectivity via USB to computer; replaces film-based radiography.

Indications for Use

Indicated for dental patients requiring radiographic imaging of the mouth. Replaces traditional film-based x-ray imaging to capture and transmit digital images for clinical analysis.

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

• RSV (Radiology System Visiodent) (K031448)
• EVA Digital Dental X-Ray System (K030647)
• Visualix Radiographic Image Detecting and Process (K925094)

Submission Summary (Full Text)

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## DENTAMERICA

KOGOGAO 510(k) Summary

APR 2 4 2006

Submission Date: February 20, 2006

Submitter's Information: Dentamerica Inc. 0 18320 Bedford Circle Industry, CA 91744

Contact Person: Eric Huang, (Product Manager) Phone: [phone] Fax: [phone]

### Establishment Registration Number: 2024949

Trade Name: Digirex™ Common Name: Digital Dental Radiography System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: 90 EHD

Performance Standard: None established under section 514 Reason for 510(k): New finished device Special controls: No applicable mandatory performance standards or special controls exist for this device.

### Substantially Equivalent Legally Marketed Devices (predicates):

RSV (Radiology System Visiodent) Device - K031448 EVA Digital Dental X-Ray System - K030647 Visualix Radiographic Image Detecting and Process - K925094

### Intended Use and Device Description:

The Digirex™ Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. A digital sensor rather than film is used to capture x-rays from an external source and produce digital images of a patient's mouth. The digital sensor and the USB controller allow the images to be transferred to a computer for analysis, archiving and electronic transmission.

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# DENTAMERICA

### Technological Characteristics and Substantial Equivalence:

The Digirex™ Digital Dental Radiography System has a number of substantially equivalent (SE) predicate devices. These predicate devices use the same technological methods to perform the task of digital image capture from an external x-ray source. A digital sensor and USB controller are the main components of the predicate devices.

Digital dental radiography eliminates the need for conventional film to produce images from an external x-ray source. The benefits of this are two-fold. First, images appear instantaneously. There is no longer a need for a dark room and chemicals to process the undeveloped x-ray film. Second, and more importantly, is that a much smaller dose of x-ray radiation is required to produce an image, benefiting the patient.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features an abstract eagle design, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular pattern around the eagle. The eagle is depicted with stylized lines, giving it a modern and symbolic appearance. The overall design is simple, clean, and conveys a sense of authority and professionalism.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

APR 2 4 2006

Mr. Eric Huang Product Manager Dentamerica, Inc. 18320 Bedford Circle INDUSTRY CA 91744

Re: K060640

Trade/Device Name: Digirex™ Digital Dental Radiography System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Il Product Code: EHD Dated: February 20. 2006 Received: March 10, 2006

Dear Mr. Huang:

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image shows a logo with the text "FDA Centennial 1906-2006" in a circular design. Below the logo, the text "Protecting and Promoting Public Health" is displayed in an elegant, cursive font. The logo commemorates the centennial of the FDA, highlighting its role in protecting and promoting public health.

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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); 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.

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 vours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

Kobob40 510(k) Number (if known):

Device Name: Digirex™ Digital Dental Radiography System

Indications for Use:

The Digirex™ Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. A digital sensor rather than film is used to capture x-rays from an external source and produce digital images of a patient's mouth. The digital sensor and the USB controller allow the images to be transferred to a computer for analysis, archiving and electronic transmission.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the Counter Use (21 CFR 801 Subpart C)

Harvey Burton

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 060640 510(k) Number