PLANMECA PROONE

K072244 · Planmeca Oy · MUH · Sep 21, 2007 · Dental

Device Facts

• Record ID: K072244
• Device Name: PLANMECA PROONE
• Applicant: Planmeca Oy
• Product Code: MUH · Dental
• Decision Date: Sep 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Indications for Use

Planmeca ProOne, dental panoramic x-ray imaging system, is an extraoral source x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device is digital, and the images are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer. The device is to be operated and used by dentists and other legally qualified professionals.

Device Story

Planmeca ProOne is a digital panoramic x-ray system; utilizes rotating tube head assembly and sensor to capture dental images; images transmitted via Ethernet to computer for display, manipulation, archiving, and communication. Operated by dentists or qualified professionals in clinical settings. Provides diagnostic visualization of teeth, jaw, and oral structures to assist clinical decision-making and patient diagnosis.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological comparison to predicate devices.

Technological Characteristics

Digital panoramic x-ray system; rotating tube head and sensor assembly; Ethernet connectivity to external computer; digital image processing and display.

Indications for Use

Indicated for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures in patients requiring dental imaging. For use by dentists and qualified professionals.

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

• Planmeca Proline with Dimax 2 (K000454)
• Planmeca Promax with DEC (K051464)

Submission Summary (Full Text)

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**PLANMECA**
ENCLOSURE 12
P. 12-1

SEF 2 1 2007

2072244
Pg 1 of 2

### 510K) SUMMARY

# DATE

August 28, 2007

### PRODUCT, CLASSIFICATION NAME

Trade name: Planmeca ProOne Common name: Panoramic x-ray system Classification: 76 EHD, Class II Regulation number: 872.1800

### MANUFACTURER

Planmeca Oy Asentajankatu 6 FI-00880 Helsinki, Finland Phone: [phone] Fax: [phone] Contact person: Lars Moring

### UNITED STATES SALES REPRESENTATIVE (U.S. DESIGNATED AGENT)

Planmeca USA Inc. 100 North Gary Avenue, Suite A Roselle, IL 60172 Phone: [phone] Fax: [phone] Contact person : Bob Pienkowski

### INTENDED USE

Planmeca ProOne, is a dental panoramic x-ray imaging system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device is digital, and the images are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer. The device is to be operated and used by dentists and other legally qualified professionals.

### PRODUCT DESCRIPTION

The Planmeca ProOne is a conventional panoramic x-ray system utilizing the digital imaging method. The tube head assembly and sensor rotates around the patient and takes a dental panoramic image of the patient. The product is a new model, with simple and reliable design, but with all necessary functions included. The computer is linked to the device via Ethernet.

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Image /page/1/Picture/0 description: The image shows the text "PLANMECA ENCLOSURE 12 P. 12-2". There is also some handwritten text below this, but it is difficult to read. The text is likely part of a document or report, and the enclosure number may refer to a specific section or appendix. The page number P. 12-2 suggests that this is page 2 of enclosure 12.

### SUBSTANTIAL EQUIVALENCE

We consider this new product to be similar in design, composition and function to the following devices introduced into commercial distribution after May 28, 1976:

Planmeca Proline with Dimax 2 # K000454 Planmeca Promax with DEC # K051464

The comparison of characteristics supports substantial equivalence. Planmeca ProOne is as safe and effective as the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

### SEP 2 1 2007

Mr. Lars Moring Regulatory Affairs Manager Planmeca Oy Asentajankatu 6 FI-00880 Helsinki FINLAND

Re: K072244

Trade/Device Name: Planmeca ProOne Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: August 8, 2007 Received: August 13, 2007

### Dear Mr. Moring:

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 individe 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 Comeice Act (Act) that do not require approval of a premarket approval application (PMA). Your Costi, therefore, market the device, subject to the general controls provisions of the Act. The greneral 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, FLA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a circular seal with the text "1906-2006" at the top. The letters "PA" are in the center of the seal. Below the letters, the word "Centennial" is written. There are three stars below the word "Centennial".

roloting and Promoting Publio Hoalth

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Page 2 -

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 yours,

Nancy Chogdon

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): K072244

Planmeca ProOne Device Name:

Indications For Use:

Planmeca ProOne, dental panoramic x-ray imaging system, is an extraoral source x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device is digital, and the images are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer. The device is to be operated and used by dentists and other legally qualified professionals.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Aran M. Whing

(Divis Sian-Uff. (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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