CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000

K070811 · Dexco · MUH · Jul 5, 2007 · Dental

Device Facts

• Record ID: K070811
• Device Name: CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000
• Applicant: Dexco
• Product Code: MUH · Dental
• Decision Date: Jul 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ADX4000 Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and pediatric subjects for taking diagnostic extraoral dental X-rays using intraoral digital or film sensors.

Device Story

ADX4000 is a battery-powered, handheld dental X-ray system; generates 60 kVp constant potential X-rays for diagnostic imaging. Operated by dentists or dental technicians in clinical settings; handheld or tripod-mounted. User selects exposure time via buttons; device produces X-rays captured by intraoral digital sensors or film. Includes circular scatter shield for radiation protection. Benefits include portability for dental imaging; facilitates diagnostic decision-making by providing extraoral X-ray images.

Clinical Evidence

Bench testing only. Device performance verified against 21 CFR 1020.30, 1020.31, and IEC60601-1-3 standards. No clinical data provided.

Technological Characteristics

Handheld, battery-powered (16.8V DC Li-Polymer) X-ray system. Fixed output 60 kVp, 1 mA. Exposure time 0.01-1.35s. Features circular scatter shield. Dimensions 5.5"H x 6.5"W x 3.2"D; weight 4.4 lbs. Complies with IEC60601-1 (electrical safety) and EN60601-1-2 (EMC).

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic extraoral dental X-rays. For use by trained dentists or dental technicians. Prescription use only.

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

• Nomad Dental X-ray System (K051795)

Submission Summary (Full Text)

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K070811.st

#### 510(k) Summary

# 031

DexcoWinA ADX4000 Cordless Portable Dental X-ray System

Common/Classification Name:

JUL - 5 2007

Unit, X-Ray, Extraoral With Timer

21 CFR 872.1800

Sponsor:

Dexco Attn: Henry Jang, Vice-President 1102, 31d E&C Venture Dream Tower 197-33 Guo-dong, Guro-gu Seoul (South) Korea

Contact:

RegTech Solutions, LLC; Attn: Robert Mazzaferro, Manager 11 Dellcastle Court; Montgomery Village, MD 20886

Prepared: March 20, 2007

LEGALLY MARKETED PREDICATE DEVICE

For its indication for use, the DexcoWinA ADX4000 Cordless Portable Dental X-ray System is substantially equivalent to the Nomad Dental X-ray System cleared by FDA under K051795.

DEVICE DESCRIPTION

The DexcoWinA ADX4000 Cordless Portable Dental X-ray System is a battery-powered hand-held dental x-ray machine whose fixed output is 60 k Vo (Constant Potential). It can be used with either a digital sensor or conventional film. This is a prescription device that can be used on pediatric and adult patients.

SUBSTANTIAL EQUIVALENCE SUMMARY

A comparison of the Dexco WinA ADX4000 Cordless Portable Dental X-ray System and the Nomad™ Dental X-ray System is presented in Table 1.

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| Feature | DexcoWinA ADX4000 (New Device) | NOMAD™ (Predicate Device K051795) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE: | The ADX4000 Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and pediatric subjects for taking diagnostic extraoral dental X-rays using intraoral digital or film sensors. | The NOMAD Dental X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subject as an extraoral diagnostic dental x-ray sources to produce X-ray images using intraoral image receptors. |
| MECHNICAL: | | |
| Size: Body | 5.5"H x 6.5"W x 3.2"D | 13"L x 11.5"H x 5.5"W |
| Weight | 4.4lbs. | 8.5lbs |
| Source to skin distance | 20cm | 20cm |
| Cone diameter | 5cm | 6cm |
| User Interface | Up-down and left-right buttons for exposure time selections with display | Up-down buttons for exposure time selections, with timer display |
| Backscatter radiation protection | Circular scatter shield | 6.75"dia. Pb-filled acrylic plastic scatter shield |
| Exposure switch | On tubehead assembly, or at control panel | On tubehead assembly/ control panel |
| Tubehead mounting | Handheld, or on a tripod | Handheld |
| ELECTRICAL: | | |
| Energy Source | Rechargeable 16.8V DC Li-Polymer battery pack | Rechargeable 14.4V DC NiCd battery pack |
| Exposure Time | 0.01-1.35 seconds in 0.01 increments | 0.01-0.99 seconds in 0.01 increments |
| Timer Accuracy | $\pm$ (10% + 1ms) | $\pm$ (10%+1ms) |
| mA | 1mA fixed | 2.3mA fixed |
| kVp | 60kVp fixed | 60kVp fixed |
| Waveform | Constant Potential (DC) | Constant Potential (DC) |
| Duty Cycle | 1:60 | 1:60 |
| Electrical Safety Standards | IEC60601-1 & others | IEC60601-1 & others. |
| Electromagnetic Standards | EN60601-1-2 & others | IEC60601-1-2 |
| X-RAY PERFORMANCE | 21 CFR 1020.30, 1020.31<br>IEC60601-1-3 | 21 CFR 1020.30, 1020.31<br>IEC60601-1-3<br>IEC60601-2-7 |

### CONCLUSION

As can be seen in the comparison table above the DexcoWinA ADX4000 & its suggested predicate, the Nomad, have the same intended use and are nearly technically the same. We therefore believe that the ADX4000 is substantially equivalent to the Nomad.

. 032

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Image /page/2/Picture/0 description: The image shows the seal for the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a human figure with three arms.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL - 5 2007

DexcoWinA % Mr. Robert Mazzaferro Manager RegTech Solutions, LLC 11 Dellcastle Court MONTGOMERY VILLAGE MD 20886

Re: K070811

Trade/Device Name: ADX4000 Cordless Portable Dental X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: June 18, 2007 Received: June 18, 2007

#### Dear Mr. Mazzafferro:

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 commence 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 movi. therefore, market the device, subject to the general controls provisions of the Act. The grateral 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 the FDA Centennial logo, which includes the years 1906-2006. Below the logo, the text "Protecting and Promoting Public Health" is written in a decorative font. The logo is circular and contains the letters FDA in a bold, stylized font. The text is slightly blurred, suggesting it may be part of a larger document or image.

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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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrl/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

510(k) Number (if known):

K070811

AND/OR

Device Name: ADX4000 Cordless Portable Dental X-ray System

Indications for Use: The ADX4000 Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and bediatric subjects for taking diagnostic extraoral dental X-rays using intraoral digital sensors or film.

× Prescription Use (Per 21 CFR 801 Subpart D)

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1.

Helena Lewin
(Division Sign Off)

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