CLEARTOOTH DIGITAL X-RAY SYSTEM

K033147 · Cleartooth Electronics, Inc. · MUH · Dec 30, 2003 · Dental

Device Facts

• Record ID: K033147
• Device Name: CLEARTOOTH DIGITAL X-RAY SYSTEM
• Applicant: Cleartooth Electronics, Inc.
• Product Code: MUH · Dental
• Decision Date: Dec 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

An extra-oral source x-ray system which is a host PC powered device that produces digital radiographs and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw and supporting oral structures.

Device Story

Cleartooth Digital X-Ray System is a PC-based software system for dental imaging. It processes digital radiographs captured from an intra-oral sensor. The system provides a graphical user interface (GUI) with standard PC features like toolbars, menus, and pop-ups, allowing clinicians to view, orient, and manipulate dental images. Used in dental clinics, the system assists dentists in diagnosing oral diseases. The output is a digital image displayed on a monitor, which supports clinical decision-making by providing clear visualization of teeth, jaw, and supporting structures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design comparison to the predicate device.

Technological Characteristics

Host PC-powered digital radiography system. Software-based image processing. Interface features include windows, toolbars, and menus for image manipulation. Operates as an extra-oral source x-ray system (21 CFR 872.1800).

Indications for Use

Indicated for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and supporting oral structures in patients requiring dental 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.

Predicate Devices

• DXS Digital X-Ray System (K013271)

Submission Summary (Full Text)

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TAB 4 - SUMMARY

Image /page/0/Picture/3 description: The image shows the logo for "cleartooth electronics". The logo consists of a stylized "C" shape enclosed in a rounded square on the left, followed by the word "cleartooth" in a bold, sans-serif font with a trademark symbol. Below "cleartooth" is the word "electronics" in a smaller, sans-serif font.

240 SAINT PAUL STREET SUITE 305 DENVER CO 80206 Phone: [phone] Fax: [phone]

## SUMMARY

Submitter's name:

Cleartooth Electronics, Inc.

Address:

240 St. Paul St., Suite 305 Denver, CO 80206

Phone:

Name of contact person:

303-733-1999

Greg Holland Requlatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] fax: [phone]

Date the summary was prepared: September 15, 2003

September 15, 2003

| Name of the device: | Cleartooth Digital X-Ray System |
|----------------------------|-------------------------------------------|
| Trade or proprietary name: | Cleartooth Digital X-Ray System |
| Common or usual name: | Extra-oral source x-ray system |
| Classification name: | System, x-ray, extra-oral source, digital |

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:

DXS DIGITAL X-RAY SYSTEM

Description of the device:

The Cleartooth Digital X-Ray System software processes standard dental images captured from a sensor device that is placed in a patient's mouth as if it were dental X-ray film. It provides users with a familiar personal computer moveable window interface, including pushbuttons, tool bars, pull-down menus, and pop-up menus. It allows users to access its features by point and click, and it allows them to work with images using intuitive and responsive features like orienting an image.

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K33141
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Indications:

An extra-oral source x-ray system which is a host PC powered device that produces digital radiographs and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw and supporting oral structures.

Summary of the technological characteristics of our device compared to the predicate device:

The predicate DXS Digital X-Ray System K013271 and Cleartooth Digital X-Ray System were compared in the following areas and found to have similar technological characteristics and to be equivalent.

Intended use Indications for use Target population Design Materials Performance Biocompatibility Mechanical safety Chemical safety Anatomical sites Where used Standards met Thermal safety Radiation safety Standards met

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cleartooth Electronics, Inc. % Mr. Greg Holland Regulatory Specialist Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606

Re: K033147

Trade/Device Name: Cleartooth Digital X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: September 29, 2003 Received: October 2, 2003

Dear Mr. Holland:

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 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.

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.

DEC 3 0 2003

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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. Brogden

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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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): KD33147

Device Name: Cleartooth Digital X-Ray System

Indications For Use:

An extra-oral source x-ray system which is a host PC powered device that produces digital radiographs and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw and supporting oral structures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="text-align:center;">✓</div> | OR | Over-The-Counter Use |
|----------------------|-----------------------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |

| | <div> <span style="text-decoration:underline;">Nancyc brondon</span> </div> <div>(Division Sign-Off)</div> <div>Division of Reproductive, Abdominal,</div> <div>and Radiological Devices</div> | |
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| REGULATORY SPECIALISTS, INC. | 510(k) Number: <span style="text-decoration:underline;">K033147</span> | Page 11 |