← Product Code [EHD](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD) · K970812

# PM 2002 CC PROLINE (K970812)

_Planmeca Oy · EHD · Aug 5, 1997 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EHD/K970812

## Device Facts

- **Applicant:** Planmeca Oy
- **Product Code:** [EHD](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD.md)
- **Decision Date:** Aug 5, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.1800
- **Device Class:** Class 2
- **Review Panel:** Dental

## 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.

## Device Story

Planmeca Dimax is an extraoral digital X-ray system for dental imaging; performs narrow beam tomography (panoramic) and cephalometric radiography. Device captures X-ray signals, converting them into digital images for dental diagnosis. Operated by dental professionals in clinical settings. Output displayed on workstation for clinician review; assists in identifying dental, jaw, and oral pathologies. Benefits include digital image acquisition, storage, and potential reduction in radiation exposure compared to traditional film-based systems.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Extraoral X-ray system; multimode imaging (panoramic and cephalometric); digital image acquisition; intended for dental applications. Technical specifications and materials not detailed in provided text.

## Regulatory 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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, 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 (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 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 QS 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 the Electronic Product 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion 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,

![img-0.jpeg](img-0.jpeg)

Lillian 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
ENCLOSURE 11
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.

Lars Moring
Regulatory Affairs Manager

Date: March 3, 1997

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number 1970812

Prescription Use ☑
(Per 21 CFR 801.109)

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