A/T X-RAY 70

K024285 · Air Techniques, Inc. · EHD · Apr 16, 2003 · Dental

Device Facts

• Record ID: K024285
• Device Name: A/T X-RAY 70
• Applicant: Air Techniques, Inc.
• Product Code: EHD · Dental
• Decision Date: Apr 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The A/T X-Ray 70 is an extra oral device designed to expose intra oral x-ray recording media (film, plates, sensors) for the purpose of radiographic examination and diagnosis of diseases of the teeth.

Device Story

A/T X-Ray 70 is an extraoral X-ray system; designed to expose intraoral recording media including film, plates, and sensors. Used by dental professionals in clinical settings for radiographic examination and diagnosis of dental diseases. Device functions as a source of ionizing radiation to capture images of teeth; output is a latent image on recording media for subsequent processing and clinical review by a dentist. Facilitates diagnostic assessment of dental health.

Clinical Evidence

No clinical data provided; device is an extraoral X-ray system subject to standard regulatory controls for dental imaging equipment.

Technological Characteristics

Extraoral X-ray system; 21 CFR 872.1800; Class II; Product Code 90 EHD. Designed for exposure of intraoral recording media (film, plates, sensors).

Indications for Use

Indicated for radiographic examination and diagnosis of dental diseases in patients requiring intraoral imaging.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 1 6 2003

Mr. Joseph Carey Director of Quality Assurance Air Techniques, Inc. 70 Cantiague Rock Road HICKSVILLE NY 11801

Re: K024285

Trade/Device Name: A/T x-ray 70 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: March 20, 2003 Received: March 26, 2003

Dear Mr. Carey:

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 (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); 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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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 the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

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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## Item 10 STATEMENT OF INDICATIONS FOR USE:

510K Number (if known):

Device Name: A/T X-Ray 70

The A/T X-Ray 70 is an extra oral device designed to expose intra oral x-ray recording media (film, plates, sensors) for the purpose of radiographic examination and diagnosis of diseases of the teeth.

## (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 Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K024285 |

| Prescription Use | <div>✓</div> (Per 21 CFR 801.109) | or | Over the counter use | (Optional Format 1-2-96) |
|------------------|-----------------------------------|----|----------------------|--------------------------|
|------------------|-----------------------------------|----|----------------------|--------------------------|

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