SOPRO595 INTRA ORAL CAMERA

K012505 · Sopro · EIA · Oct 5, 2001 · Dental

Device Facts

• Record ID: K012505
• Device Name: SOPRO595 INTRA ORAL CAMERA
• Applicant: Sopro
• Product Code: EIA · Dental
• Decision Date: Oct 5, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

Allow introl of the manation and observator

Device Story

The Sopro 595 is an intraoral camera used by dental professionals to capture and display images of the oral cavity. The device functions as a visual aid for clinical examination and patient observation. It captures optical signals from the oral environment and transmits them to a display system, allowing the clinician to visualize areas of the mouth that are difficult to see directly. This facilitates improved diagnostic assessment and patient communication. The device is intended for use in a clinical dental setting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological comparison to legally marketed predicate devices.

Technological Characteristics

Intraoral camera system. Design and specifications are comparable to existing dental imaging devices. Operates as a visual observation tool. No specific materials, energy sources, or software algorithms are detailed in the provided documentation.

Indications for Use

Indicated for intraoral examination and observation of the oral cavity.

Regulatory Classification

Identification

A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

Predicate Devices

• Air Techniques (K012505)
• Cygnus (K012505)
• Schick (K012505)

Submission Summary (Full Text)

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OCT - 5 2001

## Exhibit 9.

## 510(k) Summary

SOPRO feels the S595 Intra Oral Camera is substantially equivalent to the many marketed devices already in commercial distribution. The legally marketed devices already in commercial distribution are : Air Techniques, Cygnus, Schick just to name a few.

KO12505

The design of the S595 is virtually identical to the comparative devices, which are listed and displayed in Exhibit 2 and 3. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the same, SOPRO feels that these minor differences have no impact on the safe use and/or effectiveness of the device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the body and wings. The eagle is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 5 2001

Mr. Pierre Montillot CEO Sopro Place Street Christophe Les Accates-La Valentine Marseilla, FRANCE

Re: K012505

Trade/Device Name: Sopro 595 Intra Oral Camera Regulation Number: 872.6640 Regulation Name: Laparoscope and Accessories, General & Plastic Regulatory Class: I Product Code: EIA Dated: July 30, 2001 Received: August 3, 2001

Dear Mr. Montillot:

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 such 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

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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.

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 Part 801 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Snoer Ruano

A Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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| 510(k) Number (if known): | And Comments of the Children Comments of the Children Comments of the Children of the Children of the Children of the Children of the Children of the Children of the Children |
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Page_ 0125

Device Name: State 595 Tate Ord Camod

Indications For Use:

Allow introl of the manation and observator

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Susan Rury

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Det 510(k) Number