ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH

K994285 · Dentsply Intl. · EHD · Mar 14, 2000 · Dental

Device Facts

• Record ID: K994285
• Device Name: ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH
• Applicant: Dentsply Intl.
• Product Code: EHD · Dental
• Decision Date: Mar 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System is to be used as an extraoral source of x-rays for imaging of the dento-maxilofacial area.

Device Story

The Orthoralix 9200 is an extraoral dental X-ray system for dento-maxillofacial imaging. It utilizes a high-frequency inverter for DC power, a motorized column, and a counter-balanced overhead carriage. During operation, an X-ray tubehead and cassette holder rotate around the patient's head, which is stabilized by a bite guide and headrest. A slit diaphragm collimates the X-ray beam, and a secondary collimator blocks scattered radiation before the film. Four independent, microprocessor-controlled motors manage the radiographic projection geometry. The system includes a remote control box and handswitch for the operator. Optional features include a cephalometric arm/head positioner and 'Transcan' utilities for transverse jaw scanography. The device is intended for use by dental professionals in clinical settings to produce radiographic images that assist in diagnostic decision-making and patient treatment planning.

Clinical Evidence

No clinical trial data provided. Safety and effectiveness were demonstrated through bench performance testing, software design/performance validation, and hazard analysis.

Technological Characteristics

Extraoral X-ray system; high-frequency inverter; DC power supply; motorized column; four independent microprocessor-controlled motors for projection geometry; 15x30 cm flat film cassette; optional cephalometric arm. Connectivity includes remote control box and handswitch. Software is microprocessor-controlled for movement and technique factors.

Indications for Use

Indicated for extraoral X-ray imaging of the dento-maxillofacial area in patients requiring dental or maxillofacial diagnostic assessment.

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

• Pelton & Crane Orthophos Plus
• Instrumentarium Imaging Orthorpantomograph® OPD
• Planmeca PM 2002 CC Proline
• Gendex Orthoralix SD2/Ceph & S/Ceph

Submission Summary (Full Text)

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K994285

Image /page/0/Picture/2 description: The image shows the logos of two companies, Dentsply and Gendex, stacked vertically. The Dentsply logo is in a bold, sans-serif font with a unique, stylized 'P'. Below it, the Gendex logo is in a simpler, rounded sans-serif font. Both logos are in black and white.

GENDEX Dental X-Ray Division Dentsply International Inc. 901 West Oakton Street Des Plaines, IL 60018-1884 Phone [phone] [phone] FAX

510(k) Summary Statement for the Gendex Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System

- I General Information

| Submitter: | Gendex Dental X-Ray Division of Dentsply International, Inc<br>901 West Oakton St. |
|---------------------------------------------|------------------------------------------------------------------------------------|
| | Des Plaines, IL 60018 |
| Telephone: | [phone] - Company Number<br>[phone] - Contact Person |
| Fax: | [phone] |
| Contact Person: | William T. Cousins<br>Area Manager Quality Assurance and Regulatory Affairs |
| Summary Preparation Date: December 14, 1999 | |

#### II Names

Device Name: Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System

Primary Classification Name: 76EHD - Unit, X-Ray, Extraoral with Timer

## III Predicate Devices

- . Pelton & Crane Orthophos Plus
- Instrumentarium Imaging Orthorpantomograph® OPD ●
- Planmeca PM 2002 CC Proline
- Gendex Orthoralix SD2/Ceph & S/Ceph .

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### IV Product Description

The Dentsply/Gendex Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System is an extraoral source of x-rays for imaging of the dento-maxilofacial area.

The Dentsply/Gendex Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System is comprised of the following main components:

- High frequency inverter which supplies a true DC output and accurate technique factors
- A microprocessor controlled user-friendly electronic control
- A motorized column to be fixed to the wall .
- Counter balanced overhead carriage with controls for patient positioning, setting and . control of technique factors and radiographic projection geometry
- Cassette drive system with flat cassette for 15x30 cm film .
- X-ray tubehead, with DC power supply via electronic converter .
- Remote control box and handswitch .
- Optional cephalometric arm and head positioner ●
- Optional utilities for transverse scanography of the jaw ("Transcan®") .

During a panoramic exposure, the x-ray tube and cassette holder moves around the patient's head. The beam from the x-ray tube is collimated by a slit diaphragm. The flat film cassette passes behind a secondary collimator which blocks the radiation scattered from the patient. Patient positioning is by means of a bite guide and a headrest. During exposure, the patient, remains still while the motorized components rotate.

All movements for the panoramic radiographic projection are performed by four independent motors, which are microprocessor controlled.

## V Indications for Use / Rationale for Substantial Equivalence

The Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System is to be used as an extraoral source of x-rays for imaging of the dento-maxilofacial area.

It shares the same indications for use, similar materials, design, operational, and functional features and therefore is substantially equivalent to the predicate devices listed in section III of this summary.

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## VI Safety and Effectiveness Information

Safety and Effectiveness is demonstrated by:

- Performance testing to meet product specifications ।
- Software testing to validate software design / performance ।
- Effective clinical image exposures -
- Hazard analysis including risk level and solution ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- Same indications for use as predicate devices. -

All the above steps and evaluations combine to demonstrate that the Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System is safe and effective when the device is used as labeled.

### VII Conclusion

The Gendex Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System was found to be is Substantially Equivalent to the predicate devices; the Pelton & Crane Orthophos Plus, the Planmeca PM 2002 CC Proline, the Instrumentarium Imaging Orthorpantomograph® OPD, and the Gendex Orthoralix SD2/Ceph and S/Ceph. The Gendex Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System shares the same indications for use, similar materials, design, operational, and functional features as the current marketed predicate devices. It has been shown to be safe and effective when used as labeled.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2000

William T. Cousins Area Manager, Quality Assurance and Regulatory Affairs GENDEX Dental X-Ray Division Dentsply International, Inc. 901 West Oakton Street Des Plaines, IL 60018-1884

Re: -K994285

Orthoralix 9200 (Panoramic and Cephalometric Dental X-Ray System Dated: December 14, 1999 Received: December 20, 1999 Regulatory class: II 21 CFR 872.1800/Procode: 76 EHD

Dear Mr. Cousins:

We have reviewed your Section 510(k) notification of intent to market the device and we 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 pror 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (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 requirements, as set forth in the Quality System Requation (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 notfication submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 predication 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 [phone]. Additionally, for questions and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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# 510(k) Number (if known): Not Assigned

Device Name:

Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System

### Indications for Use:

The Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System is to be used as an extraoral source of x-rays for imaging of the dento-maxilofacial area.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stamil C. Ingram
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number .

Prescription Use (Per 21CFR 801.109)

OR

Over-The-Counter Use _

(Optional Format 1-2-96)