(39 days)
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.
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.
This document is a 510(k) summary for the Planmeca ProOne dental panoramic x-ray system. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as it predates current requirements for clinical performance data for AI/ML devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices.
Therefore, I cannot provide the requested information. The document is primarily concerned with regulatory approval based on the device's similarity to existing, legally marketed devices, rather than detailed performance metrics and clinical study results that would typically be found in more recent submissions for AI-enabled devices.
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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: +358 20 7795 500 Fax: +358 20 7795 396 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: (630) 529 2300 Fax: (630) 529 1929 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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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 (800) 638-2041 or (240) 276-3150
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
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 872.1800 Extraoral source x-ray system.
(a)
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.(b)
Classification. Class II.