ORTHOPHOS 5/PLUS/CD

K983057 · Sirona Dental Systems GmbH · MUH · Oct 22, 1998 · Dental

Device Facts

• Record ID: K983057
• Device Name: ORTHOPHOS 5/PLUS/CD
• Applicant: Sirona Dental Systems GmbH
• Product Code: MUH · Dental
• Decision Date: Oct 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Orthophos 5/PLUS/CD is an extraoral X-ray system intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The system allows for panoramic tomographic imaging, teleradiography, and transverse slice imaging.

Device Story

Orthophos 5/PLUS/CD is an extraoral X-ray system for dental imaging. It captures panoramic tomographic, teleradiographic, and transverse slice images of teeth, jaw, and oral structures. Used in dental clinics by trained professionals for diagnostic purposes. System transforms X-ray radiation into radiographic images to assist clinicians in identifying dental and oral pathologies. Benefits include non-invasive visualization of oral anatomy to support clinical decision-making and treatment planning.

Clinical Evidence

Bench testing only.

Technological Characteristics

Extraoral X-ray system; panoramic tomographic, teleradiography, and transverse slice imaging capabilities. Class II device (21 CFR 892.1800).

Indications for Use

Indicated for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures in patients requiring extraoral X-ray imaging.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 1998

Sheila M. Hemeon-Heyer, Esq., RAC Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

K983057 Orthophos 5/Plus/CD Dated: August 31, 1998 Received: September 1, 1998 Regulatory class: II 21 CFR 892.1800/Procode: 90 MUH

Dear Ms. Hemeon-Heyer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.). 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 (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 Regulation (OS) 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 notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion 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" (21 CFR 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/cdr/dsmaldsmamain.html".

Sincerely yours,

Lillian Yi, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _

Device Name: Orthophos 5/PLUS/CD

Indications For Use:

The Orthophos 5/PLUS/CD is an extraoral X-ray system intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The system allows for panoramic tomographic imaging, teleradiography, and transverse slice imaging.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _ RY8 305

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

August 31, 1998