(153 days)
The Planmeca Dimax Digital Panoramic X-ray Unit 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. This device is a multimode imaging system, which combines following imaging procedures:
- Narrow beam tomography (= panoramic mode)
- Cephalometric radiography
The use of the device is allowed only under supervision of a dentist.
The Planmeca Dimax Digital Panoramic X-ray Unit is an extraoral source X-ray system.
This letter primarily serves as an FDA clearance for the Planmeca Dimax Digital X-ray device and provides general regulatory information. It does not include details about specific acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information from the given text. The provided document is a regulatory approval letter, not a technical report or study summary that would contain performance data and acceptance criteria.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lars Moring Regulatory Affairs Manager ... Planmeca Oy·· Asentajankatu 6 FIN-00810 Helsinki, FINLAND Re: K970812
Planmeca Dimax Digital X-ray ... Dated: May 5, 1997 Received: May 7, 1997 Regulatory class: II 21 CFR 897.1800/Procode: 90 EHD
AUG - 5 1997
Dear Mr. Moring:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, 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 III (Premarket Approval), it may be الانتال such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally market 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Sincerely yours,
Nliau Yu
Lilian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ANMECA
March 3. 1997
Ref.: 510(k) Notification Extraoral source X-ray system Planmeca Dimax Digital Panoramic X-ray
INDICATIONS FOR USE
The Planmeca Dimax Digital Panoramic X-ray Unit 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. This device is a multimode imaging system, which combines following imaging procedures:
- Narrow beam tomography (= panoramic mode)
- Cephalometric radiography
The use of the device is allowed only under supervision of a dentist.
Luis leal
Lars Moring Regulatory Affairs Manager
Date: March 3, 1997
William Yin
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices Ky 510(k) Number __
Prescription Use . (Per 21 CFR 801.109)
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s
§ 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.