TOMOGRAPH ACCESSORIES

K962120 · Steri-Oss, Inc. · EHD · Jul 25, 1996 · Dental

Device Facts

• Record ID: K962120
• Device Name: TOMOGRAPH ACCESSORIES
• Applicant: Steri-Oss, Inc.
• Product Code: EHD · Dental
• Decision Date: Jul 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The tomograph accessories are indicated for use in conjunction with a tomographic x-ray system to produce radiological images.

Device Story

Device consists of accessories for tomographic x-ray systems; used to assist in positioning dental patients for cross-sectional imaging of dentition. Products are supplemental to existing radiographic units. Operated by dental staff in clinical settings to optimize radiological image acquisition.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Accessories manufactured from varying materials; designed for mechanical patient positioning support in dental tomography. No energy source or software components.

Indications for Use

Indicated for dental patients requiring radiological imaging via tomographic x-ray systems to assist in patient positioning.

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

• Siemens Orthophos Plus

Submission Summary (Full Text)

{0}

K 962120

23

STERI-OSS
A BAUSCH & LOMB Company

Original 510(k)
Tomograph Accessories
JUL 25 1996

# Section 7

## 510(k) Summary

### Manufacturer Information:

Submitter's Name: Steri-Oss Inc.

Address: 22895 Eastpark Drive
Yorba Linda, CA 92687
U.S.A.

Contact's Name: Paul Gasser
Regulatory Affairs Specialist

Phone: [phone]

Date Prepared: June 1996

### Device Names:

Common Name: Tomograph accessories

Trade Name: None

Classification Name: Tomographic X-ray system

### Predicate Device:

Substantial equivalence is claimed to Siemens Orthophos Plus.

### Device Description:

How device functions: Steri-Oss has designed a series of products to be used as a complement to a tomography system. These products aid in the positioning of dental patients for radiological imaging.

Page 1 of 2

Steri-Oss Inc. - May 1996

Steri-Oss Inc. 22895 East Park Drive Yorba Linda, CA 92687 • [phone] Fax: [phone] • [phone]

{1}

Original 510(k)
Tomograph Accessories
24

## Device Description (cont.):

Scientific concepts: A tomograph has the ability to take a cross-sectional view of dentition. In order to optimize the results obtained from tomography, patient positioning indices may be used.

Characteristics: The products submitted are manufactured of varying materials and are designed to assist in the use of a tomographic x-ray unit.

## Intended Use:

The tomograph accessories are indicated for use in conjunction with a tomographic x-ray system to produce radiological images.

## Comparison to Predicate:

The Siemens Orthophos Plus product is designed to take radiological images. As a built-in feature of this unit, it contains built-in components to aid in the positioning of the dental patient while the image is being taken.

Steri-Oss' products are designed to aid in the positioning of the dental patient as well; however, the products are intended to be supplemental to existing radiographic units.

## Performance Data:

Not applicable.

Page 2 of 2
Steri-Oss Inc. - May 1996