ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100

K973642 · Instrumentarium Imaging, Inc. · EHD · Nov 21, 1997 · Dental

Device Facts

• Record ID: K973642
• Device Name: ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100
• Applicant: Instrumentarium Imaging, Inc.
• Product Code: EHD · Dental
• Decision Date: Nov 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

Orthopantomograph® OP100 and Orthoceph® OC100 are intended to be used for producing diagnostic images of the dental arch, dentition, TM-joints and facial structures using linear tomographic method.

Device Story

The Orthopantomograph® OP100 and Orthoceph® OC100 are dental radiographic imaging systems. They utilize linear tomographic methods to capture images of the dental arch, dentition, TM-joints, and facial structures. The devices are operated by dental professionals in clinical settings to produce diagnostic images. These images assist clinicians in assessing oral and maxillofacial anatomy, supporting clinical decision-making for dental treatments and surgical planning. The systems provide high-quality radiographic output, enabling visualization of structures necessary for patient diagnosis and care.

Clinical Evidence

No clinical data provided; substantial equivalence is based on regulatory review of the device's intended use and technological characteristics compared to legally marketed devices.

Technological Characteristics

The device utilizes linear tomographic imaging technology for dental and maxillofacial applications. It is classified as a Class II device under 21 CFR 872.1800 (Procode 90 EHD).

Indications for Use

Indicated for dental and maxillofacial diagnostic imaging, including dental arch, dentition, TM-joints, and facial structures, for patients requiring radiographic 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 21 1997

RISTO Mynttinen Regulatory Affairs Intstrumentarium Corporation Imaging Division P.O. Box 20 FIN-04301 Tuusula, Finland

Re:

K973642 Orthopantomograph® OP100 and Orthoceph® OC100 Dated: September 18, 1997 Received: September 24, 1997 Regulatory class: II 21 CFR 872.1800/Procode: 90 EHD

Dear Mr. Mynttinen:

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 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 (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 OS 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,

William Yim

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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October 28, 1997

K973642 5 10(k) Number:

l Devic : Name:

ﻢ. ﻭﻣ

Orthopantomograph® OP100 and Orthoceph® OC100

ndic: tions For Use: Orthopantomograph® OP100 and Orthoceph® OC100 are intended to be Onlopantomograph - Of 100 and Chination, Then interest of dentition, TM-joints used for producing diagnostion it af race of the of the surfall and lateral images of dental arch using linear tomographic method. _______

Instrumentarium Corp. Imaging Division

Risto Mynttinen

Regulatory Affairs

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(Division Sign-Off)

( = colon of Reproductive, Abdominal, ENT,
and Radiological Devices and Radiological Devices,

510(k) Number K973642

ﮨﮯ Prescription Use. "er 21 CFR 801.109)