PLANMECA PROSENSOR

K091197 · Planmeca Oy · EHD · Jul 29, 2009 · Dental

Device Facts

• Record ID: K091197
• Device Name: PLANMECA PROSENSOR
• Applicant: Planmeca Oy
• Product Code: EHD · Dental
• Decision Date: Jul 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

Planmeca ProSensor, digital intraoral x-ray imaging system, is an accessory to dental intraoral x-ray devices. It 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.

Device Story

Planmeca ProSensor is a digital intraoral x-ray imaging system accessory. It captures x-ray images via a sensor placed in the patient's mouth. The digitized image is transmitted via Ethernet or USB to a computer. The system includes a sensor, control box, and PoE (for Ethernet). Used in dental clinics by dentists and qualified professionals. The output is displayed on a monitor for viewing, manipulation, archiving, and communication. This facilitates dental radiographic examination and diagnosis of oral structures, teeth, and jaw diseases.

Clinical Evidence

Bench testing only.

Technological Characteristics

Digital intraoral x-ray imaging system. Components: sensor, control box, PoE (Ethernet version). Connectivity: Ethernet or USB. Data transmission to computer for display, manipulation, and archiving.

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

• Planmeca Dixi2 (K000428)

Submission Summary (Full Text)

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510K) SUMMARY

DATE

April 17, 2009

JUL 2 9 2009

ENCLOSURE 12

09119

P. 12-1

## PRODUCT, CLASSIFICATION NAME

Trade name: Planmeca ProSensor Common name: Digital intraoral x-ray imaging 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 ProSensor, digital intraoral x-ray imaging system, is an accessory to dental intraoral x-ray devices. It 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 ProSensor is an accessory to the intraoral x-ray unit, and it captures the x-ray image with a sensor placed inside the patient's mouth. The digitized image is then sent either via Ethernet or a USB connection to a computer for viewing and archiving. The system consists of a sensor, a control box and a PoE (only needed for the Ethernet version).

#### SUBSTANTIAL EQUIVALENCE

We consider this new product to be similar in design, composition and function to the following device introduced into commercial distribution after May 28, 1976: # K000428 Planmeca Dixi2

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

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Planmeca Oy % Mr. Bob Pienkowski President Planmeca USA, Inc. 100 North Gary Avenue, Suite A ROSELLE IL 60172

Re: K091197

Trade/Device Name: Planmeca ProSensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: June 26, 2009 · Received: July 1, 2009

Dear Mr. Pienkowski:

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.

JUL 2 9 2009

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.

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 of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ENCLOSURE 11 . 2009-04-17 P. 11-1

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# Indications for Use

510(k) Number (if known):

KO91197

Device Name:

Planmeca ProSensor

Indications For Use:

Planmeca ProSensor, digital intraoral x-ray imaging system, is an accessory to dental intraoral x-ray devices. It 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.

V 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)

Division of

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number

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