ADX4000W

K134055 · Dexcowin Co., Ltd. · MUH · May 9, 2014 · Dental

Device Facts

• Record ID: K134055
• Device Name: ADX4000W
• Applicant: Dexcowin Co., Ltd.
• Product Code: MUH · Dental
• Decision Date: May 9, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ADX400W Cordless Portable Dental X-Ray System is indicated for use only by trained and qualified dentists or dental technicians for both adult and pediatic subjects for taking diagnostic extraoral dental x-rays using digital sensors.

Device Story

ADX4000W is a cordless, portable dental X-ray system; generates ionizing radiation for diagnostic imaging. Operated by dentists or dental technicians in clinical settings; captures extraoral dental images using digital sensors. Device provides portable X-ray source for dental diagnostics; facilitates patient imaging where stationary units are impractical. Output is radiographic image data for clinical interpretation by dental professionals; aids in diagnosis of dental conditions. Benefits include increased mobility and convenience in dental practice.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and technological comparison.

Technological Characteristics

Portable, cordless extraoral dental X-ray system. Operates as a diagnostic X-ray source for use with digital sensors. Class II device (21 CFR 872.1800).

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic extraoral dental x-rays. Use restricted to trained and qualified dentists or dental technicians.

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 is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is black and is positioned in the center of the circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper perimeter of the circle.

Public Health Service

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

May 9, 2014

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

Re: K134055

Trade/Device Name: ADX4000W Portable X-ray System Regulation Number: 21 CFR 872,1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: March 26, 2014 Received: April 10, 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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## Page 2 - Mr. Claude Berthoin

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.gov/MedicalDevices/ResourcesforYou/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.goy/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,

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

ı

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

#### 510(k) Number (if known)

# K134055

### Device Name ADX4000W Portable X-Ray System

#### Indications for Use (Describe)

The ADX400W Cordless Portable Dental X-Ray System is indicated for use only by trained and qualified dentists or dental technicians for both adult and pediatic subjects for taking diagnostic extraoral dental x-rays using digital sensors.

| | [X] 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)

Smh.7)

FORM FDA 3881 (6/13)

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

PSC Publishing Scriens [phone] EF

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