PLANMECA INTRACAM STATION

K984013 · Planmeca Oy · EIA · Jan 26, 1999 · Dental

Device Facts

• Record ID: K984013
• Device Name: PLANMECA INTRACAM STATION
• Applicant: Planmeca Oy
• Product Code: EIA · Dental
• Decision Date: Jan 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The Planmeca Intracam Station intra oral video camera system 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. The Intracam Station is an independent system, i.e. it can be used separate from a dental unit.

Device Story

Intra-oral video camera system; captures visual images of oral anatomy. Operates as independent system or accessory to dental unit. Interfaces with external video printers, monitors, and capture boards. Used by dental practitioners in clinical settings to aid visualization; facilitates image storage and retrieval for patient records. Benefits include enhanced visualization of oral structures for diagnostic or educational purposes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intra-oral video camera system. Standalone or dental unit accessory. Interfaces with standard video output devices (printers, monitors, capture boards).

Indications for Use

Indicated for use by dental practitioners to assist in viewing intra-oral anatomy and capturing/storing images for later retrieval. No specific patient population or contraindications defined.

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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Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

JAN 26 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Lars Moring Regulatory Affairs Manager Planmeca Oy Asentajankatu ર્ભ FIN-00810 Helsinki FINLAND

Re : K984013 Planmeca Intracam Station Trade Name: Requlatory Class: I Product Code: EIA Dated: November 9, 1998 Received: November 12, 1998

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 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). 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. ಕ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Moring

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin 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 requlation (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" (21CFR 807.97). Other qeneral 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/dsma/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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## PLANMECA OY

## ENCLOSURE 11

November 9, 1998

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

p. 11-1

## INDICATIONS FOR USE

The Planmeca Intracam Station intra oral video camera system 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. The Intracam Station is an independent system, i.e. it can be used separate from a dental unit.

Lus
(Signature)

Lars Moring/Regulatory Affairs Manager (Typed name/Title)

November 9. 1998 (Date)

Number) (510(k)

Susan Reaser

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices rax (KI) -510(k) Number _

PRESCRIPTION
DEVICE
(TY)

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