SIEMENS ORTHOPHOS DS/DS CEPH

K972312 · Siemens AG · EHD · Sep 15, 1997 · Dental

Device Facts

• Record ID: K972312
• Device Name: SIEMENS ORTHOPHOS DS/DS CEPH
• Applicant: Siemens AG
• Product Code: EHD · Dental
• Decision Date: Sep 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Orthophos DS / DS Ceph is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Device Story

The Orthophos DS/DS Ceph is a dental radiographic system used for imaging teeth, jaws, and oral structures. It captures X-ray data to produce diagnostic images for dental practitioners. Used in clinical dental settings, the device assists clinicians in diagnosing oral diseases. The output is a radiographic image viewed by the dentist to inform clinical decision-making and treatment planning. The system benefits patients by providing diagnostic information necessary for dental care.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Dental radiographic system; X-ray imaging technology; intended for dental diagnostic applications; class II device (21 CFR 872.1800).

Indications for Use

Indicated for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures in patients requiring dental 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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Image /page/0/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HUMAN" visible around the edge. In the center of the seal is a stylized eagle symbol, represented by three curved lines that suggest the shape of wings. The seal appears to be a government or organizational emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 1997

Siemens AG c/o Steven A. Clarke, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re:

K972312 Siemens Orthophos DS/DS Ceph Dental System Dated: June 17, 1997 Received: June 20, 1997 Regulatory class: II 21 CFR 872.1800/Procode: 90 EHD

Dear Mr. Clarke:

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, 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 requirement, as set forth in the Quality System Regulation (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 notification 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 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 question 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/cdrh/dsmamain.html".

Sincerely yours.

h. Liao Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, 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:

Indications For Use:

The Orthophos DS / DS Ceph is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

× Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Gherid li. Sijmm
(Division Sign-Off)

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