S575 INTRAORAL DOCKING DENTAL CAMERA

K990948 · Sopro · EIA · Apr 21, 1999 · Dental

Device Facts

• Record ID: K990948
• Device Name: S575 INTRAORAL DOCKING DENTAL CAMERA
• Applicant: Sopro
• Product Code: EIA · Dental
• Decision Date: Apr 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

Provide access, illumination and allow observation or manipulation of body cavities, hollow organs and canals

Device Story

SOPRO 575 Intraoral Docking Dental Camera; handheld imaging device for dental practitioners. Captures visual data of oral cavity; provides illumination and observation of dental structures. Used in dental clinics; operated by dentists or dental staff. Output displayed for clinician to facilitate examination and clinical decision-making. Benefits include enhanced visualization of oral anatomy for improved diagnostic accuracy and patient communication.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design and technological comparison to existing marketed devices.

Technological Characteristics

Intraoral dental camera; handheld form factor. Provides illumination and image capture for oral cavity visualization. Class I device (Product Code EIA).

Indications for Use

Indicated for use by clinicians to provide access, illumination, and visualization of body cavities, hollow organs, and canals for diagnostic or procedural observation and manipulation.

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.

Reference Devices

• Dentsply (unspecified)
• Dynamic (unspecified)
• Rosch (unspecified)
• Welch Allyn (unspecified)
• Air Technologies (unspecified)

Submission Summary (Full Text)

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4/21/99

## Exhibit 9.

K990948

## 510(k) Summary

SOPRO feels the S575 Dental Camera is substantially equivalent to the many marketed devices already in commercial distribution. The legally marketed devices already in commercial distribution are : Dentsply, Dynamic, Rosch, Welch Allyn, Air Technologies just to name a few.

The design of the S575 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 sames, SOPRO feels that these minors differences have no impact on the safe use and/or effectiveness of the device.

For information purposes and completeness, SOPRO has also incorporated other legally marketed devices in the filling to illustrate the wide general use of similar other devices. This wide use had led us to the safe use of this device in many practitioner's hands.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, with flowing lines above and below the profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 1999

Mr. Pierre MONTILLOT C.E.O. SOPRO Place Saint Christophe - Les Accates - La Valentine F-13011 Marseille FRANCE

Re : K990948 SOPRO 575 Intraoral Docking Dental Camera Trade Name: Requlatory Class: I Product Code: EIA Dated: March 19, 1999 March 22, 1999 Received:

Dear Mr. MONTILLOT:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. MONTILLOT

This letter will allow you to beqin 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,

Timothy A. Ulatowski
Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K990948
Page **_ of _**
510(k) Number (if known): K990948
Device Name: SOPRO 575 Docking Dental Camera
Indications For Use:
"Provide access, illumination and allow observation
or manipulation of body cavities, hollow organs
and canals"

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_✓
(Per 21 CFR 801.109)

OR

Over-The-Counter Use*_*

. Susan Buay (Optional Format 1-2-96)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K990948

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