STV PRO 2

K033419 · Trophy Radiologie · EIA · Feb 2, 2004 · Dental

Device Facts

• Record ID: K033419
• Device Name: STV PRO 2
• Applicant: Trophy Radiologie
• Product Code: EIA · Dental
• Decision Date: Feb 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The STV PRO 2 is: - a camera which delivers color images of the oral cavity, - a communication tool which allows the patient and dentist to view the patient's oral cavity

Device Story

STV PRO 2 is an intraoral camera system; captures color images of oral cavity; functions as communication tool between dentist and patient; allows real-time visualization of dental structures; used in dental clinic setting; operated by dental professionals; output displayed on monitor for patient education and clinical consultation; facilitates patient understanding of dental conditions and treatment planning.

Clinical Evidence

Bench testing only.

Technological Characteristics

Intraoral camera system; color image sensor; optical lens assembly; video output interface for display on external monitors; handheld form factor; electrical power source.

Indications for Use

Indicated for use by dentists to capture and display color images of the oral cavity for patient communication and visualization.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 2 2004

Ms. Marie-Pierre Labat- Camy Regulatory Affairs Manager Trophy Radiologie 4, Rue F. Pelloutier Croissy Beaubourg 77437 Marne-la-Vallée Cedex 2 FRANCE

Rc: K033419

Trade/Device Name: STV PRO 2 Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: January 15, 2004 Received: January 20, 2004

Dear Ms. Labat-Camy:

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 Ecderal Register.

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## Page 2 - Ms. Labat- Camy

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 mean that it Dri nas made a autes and regulations administered by other Federal agencies. of the Act of ally I occuration and sequirements, including, but not limited to: registration I ou must comply will w 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF R Far our), equality systems (QS) regulation (21 CFR Part 820); and if requirements as bet retur 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) I has letter wriftation. The FDA finding of substantial equivalence of your device to a premarket notification. The rice 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), If you desire specific at not compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Intar 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,

Chiu Lin, Ph.D.

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

Enclosure

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## Indications for Use

KO33 419 510 (k) Number (if known):

Device Name: STV PRO 2

Indication For Use :

The STV PRO 2 is:

- <> a camera which delivers color images of the oral cavity,
- <> a communication tool which allows the patient and dentist to view the patient's oral cavity

AND/OR Prescription Use x (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PI.E.A.SE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruma

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K023419

Prescription Use
( Per 21 CFR 801.109 )

Or

Over-The-Counter Use ( Optional Format 1-2-96)