PLANMECA PROMAX 3D

K060328 · Planmeca Oy · MUH · Mar 15, 2006 · Dental

Device Facts

• Record ID: K060328
• Device Name: PLANMECA PROMAX 3D
• Applicant: Planmeca Oy
• Product Code: MUH · Dental
• Decision Date: Mar 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

Planmeca Promax 3D, is a three dimensional Cone Beam Computed Tomography (CBCT) x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. The device is to be operated and used by dentists and other legally qualified professionals.

Device Story

Planmeca Promax 3D is a digital panoramic x-ray system with integrated 3D Cone Beam Computed Tomography (CBCT). Device rotates around patient; captures still images using flat panel sensor synchronized to x-ray generator pulsing. 3D reconstruction engine calculates cylindrical 3D volume image. System operated by dentists/qualified professionals in clinical settings. Output viewed on 3D workstations to assist in diagnosis of dental, jaw, and oral structure diseases.

Clinical Evidence

Bench testing only.

Technological Characteristics

Digital panoramic x-ray system with CBCT add-on; cone-shaped x-ray beam; flat panel detector; 3D reconstruction engine; cylindrical volume imaging.

Indications for Use

Indicated for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures in patients requiring dental imaging. To be used 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

• 3D Accu-i-tomo XYZ Slice View Tomograph (K052587)

Submission Summary (Full Text)

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PLANMECA
ENCLOSURE 12
P. 12-1

KOGO328

MAR 1 5 2006

# 510K) SUMMARY

DATE February 7, 2006

#### PRODUCT, CLASSIFICATION NAME

Trade name: Planmeca Promax 3D Common name: Panoramic/Tomography 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 Promax 3D, is a three dimensional Cone Beam Computed Tomography (CBCT) x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. The device is to be operated and used by dentists and other legally qualified professionals.

## PRODUCT DESCRIPTION

The Planmeca Promax 3D is in principle a conventional digital panoramic x-ray system with three-dimensional Cone Beam Computed Tomography (CBCT) system add on. The product rotates around the patient and takes still images with a flat panel sensor synchronized to x-ray generator pulsing. A 3D reconstruction engine calculates the cylindrical 3-dimensional volume image, which then is viewed in 3D viewing stations.

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# SUBSTANTIAL EQUIVALENCE

We consider this product modification including a new 3D CBCT x-ray system to be similar in design, composition and function to the following device introduced into commercial distribution after May 28, 1976:

3D Accu-i-tomo XYZ Slice View Tomograph # K052587

The comparison of characteristics supports substantial equivalence. Planmeca Promax 3D is as safe and effective as the predicate device.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2006

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

Re: K060328 Trade/Device Name: Planmeca Promax 3D Regulation Number: 21 CFR 872.1800

Regulation Name: Extraoral source x-ray system Regulatory Class: II

Product Code: MUH Dated: February 7, 2006 Received: February 9, 2006

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 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 mav, 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 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 CJFR 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.

Image /page/2/Picture/12 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo in the center. The logo is a stylized image of an eagle with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

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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 this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act irom 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/industry/support/index.html

Sincerely vours.

Nancy C. Bigelow

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):

K060328

Planmeca Promax 3D Device Name:

Indications For Use:

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is reconstructed to be viewed in 3D viewing stations welf on is reconstructed to be views the research and other legally qualified professionals.

Prescription Use
(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)

Eötvös L. Seymon

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

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