PLANMECA PROMAX 3D MID

K103689 · Planmeca Oy · MUH · Mar 17, 2011 · Dental

Device Facts

• Record ID: K103689
• Device Name: PLANMECA PROMAX 3D MID
• Applicant: Planmeca Oy
• Product Code: MUH · Dental
• Decision Date: Mar 17, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

Planmeca ProMax 3D Mid, is a panoramic and cephalometric x-ray unit, which uses Cone Beam Volumetric Tomography (CBVT) to produce three-dimensional images of the human teeth, jaws and skull. 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 health care professionals.

Device Story

Device is panoramic/cephalometric x-ray unit with CBVT add-on; rotates around patient; captures still images via flat panel detector synchronized to x-ray generator pulsing. 3D reconstruction engine calculates cylindrical 3D volume image; output viewed on 3D workstations. Operated by dentists/qualified professionals in clinical settings. Provides 3D visualization of teeth, jaws, and skull to assist in clinical diagnosis and treatment planning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital panoramic/tomography x-ray system; CBVT imaging; cone-shaped x-ray beam; flat panel detector; 3D reconstruction engine; workstation-based viewing.

Indications for Use

Indicated for dental and maxillofacial imaging of human teeth, jaws, and skull using CBVT. Intended for use by dentists and qualified healthcare 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 ProMax 3D (K060328)
• Planmeca ProMax 3D Max (K093590)

Submission Summary (Full Text)

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KI 0.3689

PLANMECA

ENCLOSURE 12

P. 12-1

## 510K) SUMMARY

MAR 1 7 2011

DATE December 14, 2010

#### PRODUCT, CLASSIFICATION NAME

Trade name: Planmeca ProMax 3D Mid Common name: Tomography x-ray system Classification: MUH, 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 Mid, is a panoramic and cephalometric x-ray unit, which uses Cone Beam Volumetric Tomography (CBVT) to produce three-dimensional images of the human teeth, jaws and skull. 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 health care professionals.

#### PRODUCT DESCRIPTION

The Planmeca ProMax 3D Max is in principle a conventional digital panoramic/tomography xray system with three-dimensional Cone Beam Volumetric Tomography (CBVT) 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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PLANMECA
ENCLOSURE 12
P. 12-2

P. 2 of 2

# SUBSTANTIAL EQUIVALENCE

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

K103689

| # K060328 | Planmeca ProMax 3D |
|-----------|------------------------|
| # K093590 | Planmeca ProMax 3D Max |

The comparison of characteristics supports substantial equivalence. Planmeca ProMax 3D Mid is as safe and effective as the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Lars Moring Regulatory Affairs Manager Planmeca Oy Asentajankatu 6 Helsinki, Finland F1-00880

MAR 1 7 2011

Re: K103689

Trade/Device Name: Planmeca Promax 3D MID Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: II Product Code: MUH Dated: December 14, 2010 Received: December 17, 2010

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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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#### Page 2- Mr. Moring

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours

Susan Tunne

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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KI03689

p. 11-1

p:1-of1

### Indications for Use

510{k) Number (if known):

Device Name:

Planmeca Promax 3D Mid

Indications For Use:

Planmeca Promax 3D Mid, is a panoramic and cephalometric x-ray unit, which uses Cone Beam Volumetric Tomography (CBVT) to produce three-dimensional images of the human teeth, jaws and skull. 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 health care 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)

Susan Ruriner

510(k) Number

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