SOPIX 2

K092329 · Sopro · MUH · Jul 20, 2010 · Dental

Device Facts

• Record ID: K092329
• Device Name: SOPIX 2
• Applicant: Sopro
• Product Code: MUH · Dental
• Decision Date: Jul 20, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The SOPIX2 system is intended to be used by qualified dentist in general to provide instant X-ray images, typically of teeth, bone and surrounding tissues

Device Story

SOPIX2 is a digital X-ray sensor system for dental and veterinary imaging. It captures X-ray radiation to produce instant digital images of teeth, bone, and surrounding tissues. Used in dental clinics by qualified dentists; the system functions as a digital sensor to replace traditional film. Output is displayed for clinical review to assist in diagnostic decision-making regarding oral health and bone structure. Benefits include immediate image availability, reducing wait times for diagnostic information.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital X-ray sensor system; extraoral source; Class II; 21 CFR 872.1800; Product Code MUH.

Indications for Use

Indicated for use by qualified dentists to provide instant X-ray images of teeth, bone, and surrounding tissues in human and veterinary applications.

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

• Accent (K050693)

Submission Summary (Full Text)

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K092325

## 9. Summary of Safety and Effectiveness – "510(k) Summary"

- A. Submitter Information
SOPRO ZAC Athélia Avenue des Genévriers 13705 La Ciotat Cedex FRANCE

JUL 2 0 2010

Telephone: [phone] · Fax: [phone]

Contact Person: Rick Rosati SOPRO c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Tel: [phone] Ext. 39 Fax: [phone] E-mail: [e-mail]

Date Prepared:

July 30, 2009

B. Device Identification

Classification Name:

system,x-ray,extraoral source,digital

Common Usual Name:

x_ray system

SOPIX2

Proprietary Name:

C. Identification of Predicate Device

| Device | Applicant | 510(k) No. | Date Cleared |
|--------|----------------|------------|--------------|
| Accent | Air Techniques | K050693 | 05/26/2005 |

The SOPIX2 system is substantially equivalent to the predicate device by Air Techniques Accent (K050963) previously cleared by the FDA and currently marketed.

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### D. Device Description

The SOPIX2 system is a digital x-ray sensor system for human and non human use in dental and veterinary applications. It is used to provide instant Xray images, typically of teeth, bone and surrounding tissues.

### E. Intended Use

The SOPIX2 system is intended to be used by qualified dentist in general to provide instant X-ray images, typically of teeth, bone and surrounding tissues

### F. Substantial Equivalence

The SOPIX2 system and the predicate device Accent , are both in Class II X-ray sensor intended to be used by qualified dentist in general to provide instant Xray images, typically of teeth, bone and surrounding tissues .Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the SOPIX2.

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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

SOPRO % Mr. Rick Rosati Official Correspondent ACTEON. Inc. 124 Gaither Drive, Suite 140 MT. LAUREL NJ 08054

Re: K092329

Trade/Device Name: SPOIX 2 System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: April 14, 2010 Received: April 15, 2010

### Dear Mr. Rosati:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

JUL 20 2010

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device . Evaluation and Safety Center for Devices and Radiological Health

#### Enclosure

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# Indications for Use

510(k) Number:

1-09 2339

Device Name:

SOPIX 2 System

Indications for Use:

The SOPIX 2 SYSTEM is intended to be used by qualified dentist in general to provide instant X-Ray images, typically of tooth, bone and surrounding tissues.

Prescription Use _ X (Part 21 CFR 801 Subpart.D) AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

DAR
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(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device E.valuation and Safety

510K K092329