ORTHOPANTOMOGRAPH OP30

K092591 · Instrumentarium Dental, Palodex Group OY · MUH · Nov 20, 2009 · Dental

Device Facts

• Record ID: K092591
• Device Name: ORTHOPANTOMOGRAPH OP30
• Applicant: Instrumentarium Dental, Palodex Group OY
• Product Code: MUH · Dental
• Decision Date: Nov 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Orthopantomograph® OP30 dental panoramic x-ray equipment is indented for dental radiographic examinations by producing digital radiographs of teeth. TM-joints and other oral structures by dentists and other legally qualified professionals.

Device Story

Orthopantomograph® OP30 is an extraoral dental X-ray system producing digital panoramic and TMJ images. Device captures X-ray projections via a digital receptor; transforms inputs into digital radiographs using technique factors (66-77 kV, 10 mA, max 10 sec). Operated by dentists or qualified professionals in clinical settings. User interface features a touch panel for setting technique factors. Output is a digital image used by clinicians to visualize oral structures, aiding in diagnosis and treatment planning. Benefits include improved diagnostic visualization of dental and TMJ anatomy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Extraoral digital X-ray system. Technique factors: 66, 70, 73, or 77 kV; 10 mA; max 10 sec exposure. Features a digital X-ray image receptor and a touch panel control interface. System is an evolution of the predicate with increased power output capabilities.

Indications for Use

Indicated for dental radiographic examinations of teeth, TM-joints, and oral structures in patients requiring dental imaging. Intended for use 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

• CRANEX® Novus (K063459)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) Summary ·

K092591

Date:

August 14, 2009

### The name of the 510(k) owner:

NOV 2 0 2009

Instrumentarium Dental, PaloDEx Group Oy Nahkelantie 160 04300 Tuusula, Finland

Tel: [phone] Fax: [phone]

Contact person: Mr. Jouni Onnela, Tel [phone]

# United States Sales Representative (U.S. Designated agent):

INSTRUMENTARIUM DENTAL INC. 300 West Edgerton Ave. Milwaukee, WI 53207 -6025 Tel: [phone] Fax: +1, 414 481 8665

Contact Person: Mr. Frank Kashinski, Tel [phone]

#### Trade name:

Orthopantomograph® OP30

#### Common name:

Dental panoramic x-ray equipment, digital

### Classification name:

System, x-ray, extraoral source, digital (21 CFR 872.1800, product code MUH)

#### Predicate device:

CRANEX® Novus (K063459, MUH)

#### Description:

Orthopantomograph® OP30 is an extraoral source dental x-ray equipment, which produces dental panoramic and TMJ images on its digital x-rav image receptor. The technique factor settings are: 66, 70, 73 or 77 kV, 10 mA and max 10 sec.

### Intended use:

The Orthopantomograph® OP30 dental panoramic x-ray equipment is indented for dental radiographic examinations by producing digital radiographs of teeth. TM-joints and other oral structures by dentists and other legally qualified professionals.

## Technological characteristics:

Orthopantomograph® OP30 is otherwise similar to the predicate device but its tube head can produce more power (70-77 kV, 10 mA) than that of the predicate device (70 kV, 7 mA) and it has a smal touch panel instead of membrane buttons for setting of technique factors.

#### Instrumentarium Dental

| Street address: | Nahkelantie 160, 04300 Tuusula Finland |
|-----------------|----------------------------------------|
| Postal address: | P.O. Box 20, FI-04301 Tuusula, Finland |
| Tel. | [phone] |
| Fax | [phone] |

Bank

SWIFT Nordea Bank NDEAFIHH Account: FI9015963000046864

PaloDEx Group Oy, Tuusula, FINLAND

{1}------------------------------------------------

# Substantial Equivalence:

and the first of the first of the first of the first of the first for the first and y

> We consider Orthopantomograph® OP30 is as safe, more effective, and performs as well as or better than the predicate device.

Instrumentarium Dental

Street address: Postal address: Tel. ESX

Nahkelantie 160, 04300 Tuusula Finland P.O. Box 20, Fl-04301 Tuusula, Finland
[phone]
[phone]

Bank

SWIFT Nordea Bank NDEAFIHH Account: FI9015963000046864

PaloDEx Group Oy, Tuusula, FINLAND

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a logo with three stylized, curved lines stacked on top of each other. The lines are thick and black, and they appear to be descending or flowing downwards. To the left of the lines, there is a partial word in a smaller font size, oriented vertically. The word is cut off, but it appears to be a department name.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Jouni Omnela Regulatory Manager Instrumentarium Dental, PaloDEx Group Oy Nahkelantie 160, 04300 Tuusula FINLAND

NOV 2 0 2009

Re: K092591

Trade/Device Name: Orthopantomograph® OP30 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: August 14, 2009 Received: August 24, 2009

#### Dear Mr. Omnela:

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.

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 (reporting of medical

{3}------------------------------------------------

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,

Janine M. Morris

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

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): K092591

Device Name: Orthopantomograph® OP30

Indications for Use:

The Orthopantomograph® OP30 dental panoramic x-ray equipment is intended for dental radiographic examinations by producing digital radiographs of teeth, TM-joints and other oral structures by dentists 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Peem

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

#### Instrumentarium Dental

Street address: Postal address: Tel. Fax

Nahkelantie 160, 04300 Tuusula Finland P.O. Box 20, FI-04301 Tuusula, Finland [phone] [phone]

Bank

SWIFT Nordea Bank NDEAFIHH Account: Fl9015963000046864

PaloDEx Group Ov Tursula FINI AND