PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the text "K051464" in a handwritten style. The text is written in black ink on a white background. The numbers are slightly distorted, giving the text a unique and informal appearance. Image /page/0/Picture/1 description: The image shows the word PLANMECA in large, bold, white letters against a black background. Below PLANMECA, the words ENCLOSURE 12 are written in a smaller, serif font. Underneath that, the text "P. 12-1" is displayed, indicating a page number or reference within the enclosure. ## 510K) SUMMARY ### DATE May 27, 2005 ## PRODUCT, CLASSIFICATION NAME Trade name: Planmeca Promax Common name: Panoramic x-ray system with cephalostat Classification: 76 EHD, Class II Regulation number: 872.1800 #### MANUFACTURER Planmeca Oy Asentajankatu 6 FI-00880 Helsinki, Finland Phone: +358 20 7795 500 Fax: +358 20 7795 396 Contact person: Lars Moring # UNITED STATES SALES REPRESENTATIVE (U.S. DESIGNATED AGENT) Planmeca USA Inc. 100 North Gary Avenue, Suite A Roselle, IL 60172 Phone: (630) 529 2300 Fax: (630) 529 1929 Contact person : Bob Pienkowski #### INTENDED USE Planmeca Promax, panoramic x-ray imaging system with cephalostat, is an extraoral source x-I lanneca I romax, panorame it to dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device can be equipped with accessories to fulfil the techt, jaw, and oftretration the images are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer. ### PRODUCT DESCRIPTION I KODOCT DESORT is a conventional panoramic x-ray system utilizing either films and r he I hanneed I rollian is g. The product can be equipped with a cephalostat. The product modification includes a new DEC (Dynamic Exposure Control) system, which is designed to be used in digital imaging, in both panoramic and cephalostat modes, and replaces the old AEC system used. {1}------------------------------------------------ ## SUBSTANTIAL EQUIVALENCE SUBSTANTIAL EQUI PALEACE We consider this product modification including a new DEC (Dynamic Exposure Control) we consider in sproduce mountion ition and function to the following devices introduced into commercial distribution after May 28, 1976: Planmeca Promax # K011619 PM 2002 Proline with AEC # K000163 The comparison of characteristics supports substantial equivalence. Planmeca Promax with DEC is as safe and effective as the predicate devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Bob Pienkowski Managing Director Planmeca USA, Inc. 100 North Gary Avenue, Suite A ROSELLE IL 60172 Re: K051464 . JUN 2 4 2005 Trade/Device Name: Planmeca Promax with DEC (Dynamic Exposure Control) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD and MUH Dated: May 27, 2005 Received: June 3, 2005 Dear Mr. Pienkowski: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced in we have reviewed your Section 910(t) proisentially equivalent (for the indications for use stated in above and have decemined the device is accessions of the enclosure) to tegally marketed predisate active in to devices that have been the Arthur May 26, 1970, the enactificant and of the Federal Food, Drug, and Cosmetic Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act reclassified in accordance with the proval application (PMA). You may, therefore, market the do not require approval of a premaince approval septimation (The general controls provisions of the Act device, subject to the general controls provisions of the Act. The ge device, subject to the general controls provisions 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 If your device is classified (300 additional controls. Existing major regulations affecting your Apploval), it they of subject to back aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA device can be found in the Sourcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FIEASE be advised that I DX 3 issumited on aevice complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Federal statucs and regulations administration and listing (21 CFR Part 807); labeling Act s requirements, medading, but not minted to requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 5 10(k) 10 1 leggly of the first of a first of a location international of your device This letter will anow you to begin maneting your antial equivalence of your device to a legally premarket notification. The FDA miding of saosantial or 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), pleased If you desire specific advice for your device of our may beging numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premated notification" (21 CFR Also, please note the regulation entities; "Firstenant on your responsibilities under the Act from the 807.97). You may obtain other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C. Hogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Planmeca Oy 510(k) Notification Planmeca Promax with DEC # INDICATIONS FOR USE Planmeca Promax, panoramic x-ray imaging system with Cephalostat, is an extraoral source xand the survey and and sected as the counting and diagnosis of diseases of Planneca Promax, panoramic x-ray magnic examination and disensis of diseases of ray system, which is intended for and radiographic examination and diseases of eray system, wh ray system, which is intended for deltar ractorial with accessories to fulfil the teeth, jaw, and oral structures. The active can overspeared isplayed on a monitor, and different diagnostic needs. In digital configuration the scomputer different diagnostic needs. In digital connigulation are performed via a computer. image manipulation, archiving and communication are performed via a computer. Helsinki, May 27, 2005 Luis le Roy Lars Moring Regulatory Affairs Managel Planmeca Oy *Prescription Use* ✓ Nancy Brogdon (Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number