ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD

K972249 · Pelton & Crane Co. · EHD · Sep 12, 1997 · Dental

Device Facts

• Record ID: K972249
• Device Name: ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD
• Applicant: Pelton & Crane Co.
• Product Code: EHD · Dental
• Decision Date: Sep 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Orthophos Plus and Orthophos Plus/CD are intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The X-ray source is located outside the mouth.

Device Story

Extraoral X-ray system for dental imaging; produces panoramic radiographs of teeth, maxillary sinuses, and temporal mandibular joints; provides transverse panoramic tomographs of lateral, canine, and anterior maxillary/mandibular regions. Device includes 23 factory-installed imaging programs, bite blocks, and head positioning accessories; optional cephalometric attachment (Orthophos Plus/CD). Operated by dental professionals in clinical settings. System uses primary and secondary collimators to define X-ray beam geometry for specific anatomical slices. Clinicians use resulting images to diagnose maxillofacial diseases. Benefits include comprehensive visualization of oral structures for improved diagnostic accuracy.

Clinical Evidence

No clinical data provided; substantial equivalence based on technical comparison and design modifications to the predicate device.

Technological Characteristics

Extraoral X-ray system; 23 factory-installed imaging programs; primary and secondary collimators for transverse slice imaging; includes bite blocks and head positioning accessories; optional cephalometric attachment. 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 panoramic imaging of the maxillofacial region or transverse slice imaging of the maxillary and mandibular regions.

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

• Orthophos (K895467)
• Orthophos C (K895467)

Submission Summary (Full Text)

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

# SEP 1 2 1997

### 510(k) Summary

## Orthophos Plus and Orthophos Plus/CD

#### Sponsor 1.

Pelton & Crane A Siemens Company P.O. Box 7800 Charlotte, NC 28241-7800 Tel: [phone] [phone] Fax:

Duronnie Harrell Contact Person: Director, Quality Assurance and Regulatory Affairs

June 12, 1997 Date Prepared:

#### Device Name 2.

Classification Name: Extraoral source X-ray system, 21 CFR 872.1800, Class II

Orthophos Plus and Orthophos Plus/CD Proprietary Name:

#### Intended Use 3.

The Orthophos Plus and Orthophos Plus/CD are intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The X-ray source is located outside the mouth.

#### Device Description 4.

The Orthophos Plus contains 23 factory installed programs that allow for comprehensive imaging of the entire maxillofacial region. The Orthophos Plus software programs allow for panoramic radiographs of the teeth, maxillary sinuses, and temporal mandibular joints, as well as transverse panoramic tomographs of the lateral, canine and anterior maxillary and mandibular regions. The device is

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

equipped with various bite block and head positioning accessories. The device is also available with an optional cephalometric attachment (Orthophos Plus/CD).

#### Basis For Substantial Equivalence 5.

The Orthophos Plus and Orthophos Plus/CD are substantially equivalent to the Orthophos and Orthophos C which were cleared for marketing under K895467. The Orthophos Plus is a revised version of the Orthophos and differs from the Orthophos as follows:

- Eleven additional programs have been added to the Orthophos Plus to allow (1) for additional views of the maxillofacial regions.
- Additional primary and secondary collimators have been added to allow for (2) the transverse slice imaging.
- Additional patient head positioning and bite block accessories have been (3) added to allow for the transverse slice imaging.

These technical changes do not alter the intended use of the device, nor do they raise new questions of safety and effectiveness.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 1997

Re:

Pelton & Crane c/o Sheila Hemeon-Hever, JD, RAC Regulatory Services Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

K972249 Orthophos Plus and Orthophos Plus/CD (Dental X-Ray System) Dated: June 12, 1997 Received: June 16, 1997 Regulatory class: II

21 CFR 872.1800/Procode: 90 EHD

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 requirement, 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 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/cdrh/dsmamain.html".

Sincerely yours,

h. William Yiu, Ph.D.

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

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

510(k) Number (if known): _

Orthophos Plus and Orthophos Plus/CD Device Name:

Indications For Use:

The Orthophos Plus and Orthophos Plus/CD are intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The X-ray source is located outside the mouth. The system provides for panoramic imaging of the entire maxillofacial region as well as transverse slice imaging of the maxillary and mandibular regions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Seymore
(Division Sign-Off)

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

Prescription Use
(Per 21 CFR 801.109)

OR Over-The-Counter Use

6/12/97