DX3000-L

K133007 · Dexcowin Co., Ltd. · MUH · Apr 24, 2014 · Dental

Device Facts

• Record ID: K133007
• Device Name: DX3000-L
• Applicant: Dexcowin Co., Ltd.
• Product Code: MUH · Dental
• Decision Date: Apr 24, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

DX3000 is a portable x-ray system indicated for taking diagnostic dental x-rays for both pediatic and adult patients using intraoral film or digital sensors

Device Story

DX-3000 is a portable dental X-ray system; generates ionizing radiation for diagnostic imaging. Operated by dental professionals in clinical settings. Device captures X-ray images using intraoral film or digital sensors. Provides clinicians with radiographic visualization of dental structures to assist in diagnosis of oral conditions. Benefits include portability for point-of-care imaging within dental offices.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and technological comparison to legally marketed predicate devices.

Technological Characteristics

Portable extraoral X-ray system; 21 CFR 872.1800; Class II; Product Code MUH. Designed for use with intraoral film or digital sensors. Operates as a source of ionizing radiation for dental diagnostic imaging.

Indications for Use

Indicated for diagnostic dental x-ray imaging in pediatric and adult patients using intraoral film or digital sensors.

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.

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird-like figure with flowing lines.

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

April 24, 2014

Denterprise International, Inc. % Claude Berthoin President 110 East Granada Blvd., Suite 207 ORMOND BEACH, FL 32176

Re: K133007

Trade/Device Name: DX-3000 Portable X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: April 08, 2014 Received: March 28, 2014

### Dear Mr. Berthoin:

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh 7?

for

Janine M. Morris 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

510(k) Number (if known) K133007

#### Device Name

DX3000 Portable X-Ray System

#### Indications for Use (Describe)

DX3000 is a portable x-ray system indicated for taking diagnostic dental x-rays for both pediatic and adult patients using intraoral film or digital sensors

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

図 Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

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