PLANMECA INTRACAM

K972033 · Planmeca Oy · EIA · Jun 20, 1997 · Dental

Device Facts

• Record ID: K972033
• Device Name: PLANMECA INTRACAM
• Applicant: Planmeca Oy
• Product Code: EIA · Dental
• Decision Date: Jun 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The Planmeca IntraCam intra oral video camera is a dental operative unit accessory, which is intended for use by practitioners in the dental field for use as an aid or adjunct to assist in viewing intra oral anatomies and capturing and storing images for later retrieval. The camera interfaces with video printers, TV/monitors, capture boards etc., and is designed to be located as an instrument in a dental unit.

Device Story

Planmeca IntraCam is an intra-oral video camera accessory for dental operative units. Device captures visual data of intra-oral anatomy; transmits signal to external peripherals including video printers, TV/monitors, and capture boards. Operated by dental practitioners in clinical settings to assist in visual examination and documentation. Output allows clinicians to view live or stored images to aid in clinical assessment and patient communication.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intra-oral video camera; interfaces with standard video output devices (printers, monitors, capture boards); designed for integration into dental operative units.

Indications for Use

Indicated for use by dental practitioners as an aid to view intra-oral anatomy and capture/store images for later retrieval.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 20 1997

Mr. Lars Morinq Requlatory Affairs Manager Planmeca Oy Asentajankatu 6 FIN-00810 Helsinki, FINLAND

K972033 Re: Planmeca Intracam Trade Name: Regulatory Class: I Product Code: EIA Dated: May 29, 1997 Received: June 2, 1997

Dear Mr. Moring:

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, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 requlatory 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 requlations.

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Page 2 - Mr. Rigby

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 Smakl Manufacturers Assistance at its toll-free number [phone] or at [phone].

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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May 29, 1997

Ref.: 510(k) Notification Accessory to Dental Operative Unit Planmeca IntraCam

## INDICATIONS FOR USE

The Planmeca IntraCam intra oral video camera is a dental operative unit accessory, which is intended for use by practitioners in the dental field for use as an aid or adjunct to assist in viewing intra oral anatomies and capturing and storing images for later retrieval. The camera interfaces with video printers, TV/monitors, capture boards etc., and is designed to be located as an instrument in a dental unit.

Lus leoly

Lars Moring Regulatory Affairs Manager

Date: May 29, 1997

Swee Runner

(Division Sign-Off Division of Dental, Infection Con and General Hospital I 510(k) Numbai