MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM

K013659 · Sirona Dental Systems GmbH · MUH · Dec 6, 2001 · Dental

Device Facts

• Record ID: K013659
• Device Name: MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
• Applicant: Sirona Dental Systems GmbH
• Product Code: MUH · Dental
• Decision Date: Dec 6, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The SIDEXIS is a digital imaging system intended to replace conventional radiographic film for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Device Story

SIDEXIS is a digital radiography imaging system replacing conventional film for dental diagnostics. System components include intraoral and extraoral X-ray sensors, image acquisition boards (XAB), and software installed on IBM-compatible PCs. The system interfaces with Orthophos Plus DS/Plus DS Ceph extraoral X-ray devices via Ethernet and uses a USB box for intraoral sensor connectivity. It captures digital X-ray images, including transverse slice imaging, for display and analysis by dental clinicians. The system facilitates dental radiographic examination and diagnosis of teeth, jaw, and oral structures, aiding clinical decision-making through digital image acquisition and processing.

Clinical Evidence

No clinical data. Substantial equivalence supported by hazard analysis and validation testing.

Technological Characteristics

System comprises intraoral/extraoral digital X-ray sensors, XAB image acquisition board, and USB interface box. Operates with IBM-compatible PCs. Connectivity via Ethernet and USB. Software version 5.5. Digital transverse slice imaging capability.

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.

Predicate Devices

• SIDEXIS Digital Radiography System (K992644)

Submission Summary (Full Text)

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1L0/3459

# Special 510(k) Summary

### for

## SIDEXIS Digital Radiography Imaging System

#### SPONSOR 1.

DEC 0 6 2001

Sirona Dental Systems GmbH Fabrikstraße 31 D-64625 Bensheim Germany

Contact Person: Fritz Kolle 49 6251 16 3294 Telephone:

November 5, 2001 Date Prepared:

#### DEVICE NAME 2.

SIDEXIS Digital Radiography Imaging System Proprietary Name: Common/Usual Name: Digital X-ray Imaging System Accessory to Extraoral Source X-ray System Classification Name:

#### PREDICATE DEVICE 3.

SIDEXIS Digital Radiography System -- K992644

#### 4. INTENDED USE

.

The SIDEXIS is a digital imaging system intended to replace conventional radiographic film for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

#### DEVICE DESCRIPTION હ્

SIDEXIS consists of intraoral and extraoral digital X-ray sensors, image acquisition boards, and software to be installed into an IBM-compatible personal computer. This

November 5, 2001 Sirona Dental Systems GmbH Special 510(k) SIDEXIS Digital Radiography Imaging System

Page E-1

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Special 510(k) is being submitted to document a new sensor and associated software for digital transverse slice imaging in conjunction with the Orthophos Plus DS / Plus DS Ceph family of digital extraoral source X-ray imaging devices. Other minor modifications discussed in this Special 510(k) include: 1) a new XAB image acquisition board to interface SIDEXIS to the Orthophos X-ray systems via the Ethernet; 2) a new USB (Universal Serial Bus) Box to interface the SIDEXIS with the intraoral sensors; and 3) software enhancements to improve the overall function of SIDEXIS (resulting in software version 5.5).

#### BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The SIDEXIS system that is the subject of this 510(k) premarket notification is a modification of SIDEXIS as previously cleared for marketing under K992644. The modified SIDEXIS has the same intended use and principles of operation as the original SIDEXIS, as well as substantially equivalent technical specifications. A hazard analysis, validation testing, and Declaration of Conformity to Design Controls were submitted to support the substantial equivalence of the modified SIDEXIS Digital Radiography Imaging System.

Sirona Dental Systems GmbH Special 510(k) SIDEXIS Digital Radiography Imaging System

November 5, 2001

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing segments.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 6 2001

Sirona Dental Systems, Inc. % Ms. Sheila M. Hemeion-Heyer Medical Device Consultants 49 Plain Street NORTH ATTLEBORO MA 02760 Re: K013659 Trade/Device Name: SIDEXIS Digital Radiography Imaging System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: November 5, 2001 Received: November 6, 2001

Dear Ms. Hemeion-Heyer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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 notification. The I Drice 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), please If you desire specific acvies to your as a one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions of [phone]. Also, please note the regulation entitled, "Misbranding Other of Compilance at (2017 22ation" (21 CFR Part 807.97). Other general information on of felected to premained nothers and the Division of Small Manufacturers, your responsional and Consumer at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, 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: SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM

Indications For Use:

SIDEXIS is a digital radiography imaging system intended to replace conventional radiographic film 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)

Elmer A. Sperry

(Division Sign-Off) Division of Reproductive, and Radiological Devic 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Sirona Dental Systems GmbH Special 510(k) SIDEXIS Digital Radiography Imaging System November 5, 2001